Biopsy device with fine pitch drive train

ABSTRACT

A biopsy device includes a cutter and a probe body. A cutter rotation and translation mechanism may include a sleeve that is secured to the cutter, a nut that is secured to the body, and first and second gears. The sleeve includes portion having external threads and a portion having external flats. The nut has internal threads that are configured to engage the threads of the sleeve, such that the cutter translates longitudinally when the sleeve rotates within the nut. The threads have a fine pitch (e.g., 40-50 threads per inch). The first gear is slid onto the portion of the sleeve that has flats, and is configured to rotate with the sleeve yet translate along the sleeve. The second gear is coupled with a motor. The second gear is configured to mesh with the first gear to rotate the sleeve, thereby concomitantly rotating and translating the cutter.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, orotherwise. Merely exemplary biopsy devices are disclosed in U.S. Pat.No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pub. No. 2003/0109803, entitled “MRICompatible Surgical Biopsy Device,” published Jun. 12, 2003; U.S. Pub.No. 2007/0118048, entitled “Remote Thumbwheel for a Surgical BiopsyDevice,” published May 24, 2007; U.S. Provisional Patent ApplicationSer. No. 60/869,736, entitled “Biopsy System,” filed Dec. 13, 2006; andU.S. Provisional Patent Application Ser. No. 60/874,792, entitled“Biopsy Sample Storage,” filed Dec. 13, 2006. The disclosure of each ofthe above-cited U.S. Patents, U.S. Patent Application Publications, andU.S. Provisional Patent Applications is incorporated by referenceherein. While several systems and methods have been made and used forobtaining a biopsy sample, it is believed that no one prior to theinventors has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a schematic view of an exemplary biopsy system;

FIG. 2 depicts a perspective view of an exemplary assembled biopsydevice, for use in a stereotactic setting;

FIG. 3 depicts an exploded view of the biopsy device of FIG. 2, with theprobe detached from the holster;

FIG. 4 depicts a perspective view of an exemplary assembled biopsydevice, for use in an ultrasound setting;

FIG. 5 depicts an exploded view of the biopsy device of FIG. 4, with theprobe detached from the holster;

FIG. 6 depicts a top perspective view of a probe portion of the biopsydevice of FIG. 3;

FIG. 7 depicts a bottom perspective view of the probe portion of FIG. 6;

FIG. 8 depicts a top perspective view of the probe portion of FIG. 6,with a top cover removed;

FIG. 9 depicts a bottom perspective view of the probe portion of FIG. 6,with a base removed;

FIG. 10 depicts a lateral cross-sectional view of the probe portion ofFIG. 6, taken along a longitudinal plane;

FIG. 11 depicts a perspective view of a needle component of the probeportion of FIG. 6;

FIG. 12 depicts a partial perspective view of the probe portion of FIG.6, showing a needle hub assembly;

FIG. 13 depicts a partial perspective view of the probe portion of FIG.6, showing a needle hub assembly with a needle manifold removed;

FIG. 14 depicts a partial, cross-sectional view of a cutter rotation andtranslation mechanism of the probe portion of FIG. 6, taken along alongitudinal plane;

FIG. 15 depicts a front perspective view of an exemplary tissue sampleholder;

FIG. 16 depicts the tissue sample holder of FIG. 15, with a cup andother components removed;

FIG. 17 depicts the tissue sample holder of FIG. 15, with a tissuesample tray removed;

FIG. 18 depicts a rear view of the tissue sample holder of FIG. 15;

FIG. 19 depicts a rear view of the tissue sample holder of FIG. 15, witha cup and other components removed;

FIG. 20 depicts a perspective view of an engagement member;

FIG. 21 depicts an exploded view of an applier and the tissue sampleholder of FIG. 15;

FIG. 22 depicts a perspective view of the applier of FIG. 21 inserted inthe tissue sample holder of FIG. 15;

FIG. 23 depicts a perspective view of a holster of the biopsy device ofFIG. 2;

FIG. 24 depicts a top view of the holster of FIG. 23, with a top coverremoved;

FIG. 25 depicts a side view of the holster of FIG. 23, with side panelsremoved;

FIG. 26 depicts another side view of the holster of FIG. 23, with sidepanels removed;

FIG. 27 depicts a partial view of the holster of FIG. 23, showing anexemplary needle rotation mechanism;

FIG. 28 depicts a partial view of the holster of FIG. 23, showing anexemplary needle firing mechanism;

FIG. 29 depicts a partial view of the holster of FIG. 23, showing anexemplary needle firing mechanism in a cocked configuration;

FIG. 30 depicts a partial view of the holster of FIG. 23, showing anexemplary cutter drive mechanism;

FIG. 31 depicts a partial view of the holster of FIG. 23, showing anexemplary tissue holder rotation mechanism;

FIG. 32 depicts another partial view of the holster of FIG. 23, showingan exemplary tissue holder rotation mechanism;

FIG. 33 depicts a bottom perspective view of the probe portion of thebiopsy device of FIG. 4;

FIG. 34 depicts a top perspective view of the probe portion of FIG. 33,with a top cover removed;

FIG. 35 depicts a bottom perspective view of the probe portion of FIG.33, with a base removed;

FIG. 36 depicts a partial perspective view of the probe portion of FIG.33, showing a needle hub assembly;

FIG. 37 depicts a partial perspective view of the probe portion of FIG.33, showing a needle hub assembly with a needle manifold removed;

FIG. 38 depicts a front perspective view of an exemplary tissue sampleholder, with a cup and other components removed;

FIG. 39 depicts the tissue sample holder of FIG. 38, with a tissuesample tray removed;

FIG. 40 depicts a rear view of the tissue sample holder of FIG. 38, witha cup and other components removed;

FIG. 41 depicts a front perspective view of a holster of the biopsydevice of FIG. 4;

FIG. 42 depicts a rear perspective view of the holster of FIG. 41;

FIG. 43 depicts a top view of the holster of FIG. 41, with a top coverremoved;

FIG. 44 depicts a partial view of the holster of FIG. 41, showing anexemplary cutter drive mechanism;

FIG. 45 depicts a partial view of the holster of FIG. 41, showing anexemplary tissue holder rotation mechanism;

FIG. 46 depicts a perspective view of an exemplary vacuum control moduleand exemplary vacuum canister;

FIG. 47 depicts the vacuum control module of FIG. 46 with the vacuumcanister of FIG. 46 separated therefrom;

FIG. 48 depicts a perspective view of the vacuum canister of FIG. 46;

FIG. 49 depicts a top view of the vacuum canister of FIG. 46;

FIG. 50 depicts a top view of the vacuum canister of FIG. 46, with tubesengaged with a top portion of the canister;

FIG. 51 depicts a cross-sectional view of the canister of FIG. 46, takenalong a longitudinal plane;

FIG. 52 depicts a rear perspective view of the vacuum control module ofFIG. 46;

FIG. 53 depicts the vacuum control module of FIG. 46, with an outercasing removed;

FIG. 54 depicts a perspective view of a vacuum canister port assembly ofthe vacuum control module of FIG. 46;

FIG. 55 depicts a front view of the vacuum canister port assembly ofFIG. 54;

FIG. 56 depicts a rear view of the vacuum canister port assembly of FIG.54;

FIG. 57 depicts a cross-sectional view of the vacuum canister portassembly of FIG. 54;

FIG. 58 depicts a cross-sectional view of the vacuum canister portassembly of FIG. 54 with the vacuum canister of FIG. 46 insertedtherein;

FIG. 59 depicts a perspective, cross-sectional view of an exemplarytube;

FIG. 60 depicts a schematic flow diagram showing an exemplary rotationsequence of a tissue sample holder;

FIG. 61 depicts an exemplary sequence of the position of a cutter withina cannula, relative to fluid communication being provided throughlateral and axial vacuum tubes, in an exemplary “sample” cycle;

FIG. 62 depicts an exemplary sequence of the position of a cutter withina cannula, relative to fluid communication being provided throughlateral and axial vacuum tubes, in an exemplary “clear probe” cycle;

FIG. 63 depicts an exemplary sequence of the position of a cutter withina cannula, relative to fluid communication being provided throughlateral and axial vacuum tubes, in an exemplary “position” cycle;

FIG. 64 depicts an exemplary sequence of the position of a cutter withina cannula, relative to fluid communication being provided throughlateral and axial vacuum tubes, in an exemplary “aspirate” cycle;

FIG. 65 depicts an exemplary sequence of the position of a cutter withina cannula, relative to fluid communication being provided throughlateral and axial vacuum tubes, in an exemplary “smart vac” cycle;

FIG. 66 depicts an exemplary “status” page of an exemplary userinterface for a biopsy system;

FIG. 67 depicts an exemplary “probe” page of an exemplary user interfacefor a biopsy system;

FIG. 68 depicts an exemplary “system” page of an exemplary userinterface for a biopsy system; and

FIG. 69 depicts an exemplary user interface that may be applied to aportion of a biopsy device.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

As shown in FIG. 1, an exemplary biopsy system (2) includes a biopsydevice (100, 101) and a vacuum control module (400). As shown in FIGS.2-3, biopsy device (100) comprises a probe (102) and a holster (202).Similarly, as shown in FIGS. 4-5, biopsy device (101) comprises a probe(103) and a holster (302). As will be described in greater detail below,each probe (102, 103) is separable from its corresponding holster (202,302). Use of the term “holster” herein should not be read as requiringany portion of probe (102, 103) to be inserted into any portion ofholster (202, 302). Indeed, in some variations of biopsy devices (100,101), probe (102, 103) may simply sit on holster (202, 302). In someother variations, a portion of holster (202, 302) may be inserted intoprobe (102, 103). Furthermore, in some biopsy devices (100, 101), probe(102, 103) and holster (202, 302) may be of unitary or integralconstruction, such that the two components cannot be separated. Stillother suitable structural and functional relationships between probe(102, 103) and holster (202, 302) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Some variations of biopsy devices (100, 101) may include one or moresensors (not shown), in probe (102, 103) and/or in holster (202, 302),that is/are configured to detect when probe (102, 103) is coupled withholster (202, 302). Such sensors or other features may further beconfigured to permit only certain types of probes (102, 103) andholsters (202, 302) to be coupled together. In addition or in thealternative, such sensors may be configured to disable one or morefunctions of probes (102, 103) and/or holsters (202, 302) until asuitable probe (102, 103) and holster (202, 302) are coupled together.Of course, such sensors and features may be varied or omitted asdesired.

By way of example only, probe (102, 103) may be provided as a disposablecomponent, while holster (202, 302) may be provided as a reusablecomponent. Vacuum control module (400) is provided on a cart (not shown)in the present example, though like other components described herein, acart is merely optional. Among other components described herein, afootswitch (not shown) and/or other devices may be used to provide atleast some degree of control of at least a portion of biopsy system (2).Conduits (200) provide communication of power (e.g., electrical,pneumatic, etc.), control signals, saline, vacuum, and venting fromvacuum control module (400) to biopsy device (100, 101). Each of thesecomponents will be described in greater detail below.

I. Exemplary Probe for Stereotactic Use

As shown in FIGS. 6-14, probe (102) comprises a needle portion (10) anda body portion (112). Body portion (112) comprises a cover member (114)and a base member (116). A tissue sample holder (140) is removablysecured to base member (116), though tissue sample holder (140) mayalternatively be secured to cover member (114) or some other component.As will be described in greater detail below, a pair of tubes (402, 404)are coupled with probe (102).

A. Exemplary Needle

In the present example, needle portion (10) comprises an outer cannula(12) having a tissue piercing tip (14) and a transverse tissue receivingaperture (16) located proximally from the tissue piercing tip (14).Tissue piercing tip (14) is configured to penetrate tissue withoutrequiring a high amount of force, and without requiring an opening to bepreformed in the tissue prior to insertion of tip (14). Suitableconfigurations for tissue piercing tip (14) will be apparent to those ofordinary skill in the art in view of the teachings herein. For instance,as shown in FIG. 11, tip (14) of the present example is part of a needlepiece (18), which is formed of a stamped piece of metal. In particular,needle piece (18) is stamped to form tip (14) and wall (30), which willbe described in greater detail below. A plurality of openings (32),including venting openings (34) are formed through wall. Various ways inwhich fluid may be communicated through openings (32, 34) will bedescribed in greater detail below, with reference to FIGS. 61-65. Needlepiece (18) is then twisted such that tip (14) and wall (30) aresubstantially perpendicular to one another. Needle piece (18) is theninserted into cannula (12), with tip (14) protruding through a slotformed in the distal end of cannula (12). A tissue stop (26) is providedimmediately proximal to tip (14). Still other ways in which tip (14) maybe formed, including alternative techniques, materials, andconfigurations, will be apparent to those of ordinary skill in the artin view of the teachings herein.

The interior of outer cannula (12) of the present example defines acannula lumen (20) and a vacuum lumen (40), with a wall (30) separatingthe cannula lumen (20) from the vacuum lumen (40). A plurality ofexternal openings (22) are formed in outer cannula (12), and are influid communication with vacuum lumen (40). Examples of openings thatare similar to external openings (22) are disclosed in U.S. Pub. No.2007/0032742, entitled “Biopsy Device with Vacuum Assisted BleedingControl,” published Feb. 8, 2007, the disclosure of which isincorporated by reference herein. Of course, as with other componentsdescribed herein, external openings (22) are merely optional.

In some embodiments, wall (30) extends a substantial amount of thelength of needle portion (10). In other embodiments, wall (30)proximally extends just past the region where the distal end of a cutter(50), which will be described below, terminates in needle portion (10).For instance, cannula lumen (20) may be sized and configured such that,with cutter (50) disposed therein, a gap exists between the exterior ofcutter (50) and at least a portion of the interior of cannula (12). Sucha gap may provide a vacuum lumen (40) along the length of cannula (12)proximal to the proximal end of wall (30). Still other ways in which avacuum lumen (40) may be provided will be apparent to those of ordinaryskill in the art in view of the teachings herein.

In the present example, a plurality of transverse openings (32, 34) areformed through wall (30) to provide fluid communication between cannulalumen (20) and vacuum lumen (40). As will be described in greater detailbelow, vacuum, saline, and/or pressurized air may be communicated fromvacuum lumen (40) to cannula lumen (20) via transverse openings (32,34).

B. Exemplary Cutter

A hollow cutter (50) is disposed within cannula lumen (20). The interiorof cutter (50) defines a cutter lumen (52), such that fluid and tissuemay be communicated through cutter (50) via cutter lumen (52). As willbe described in greater detail below, cutter (50) is configured torotate within cannula lumen (20) and translate axially within cannulalumen (20). In particular, cutter (50) is configured to sever a biopsysample from tissue protruding through transverse aperture (16) of outercannula (12). As will also be described in greater detail below, cutter(50) is further configured to permit severed tissue samples (4) to becommunicated proximally through cutter lumen (52). Merely illustrativeexamples of such severing and proximal communication are described inU.S. Pat. No. 5,526,822, the disclosure of which is incorporated byreference herein, though any other suitable structures or techniques maybe used for severing and/or communicating tissue samples (4) within abiopsy system (2).

Cutter (50) may be subject to various treatments or configurations inorder to facilitate proximal communication of tissue samples (4) throughcutter lumen (52). For instance, the surface finish inside of cutter(50), defining cutter lumen (52), may be subject to shot peening (e.g.,with glass beads, sodium bicarbonate, etc.) to reduce adhesion betweentissue and cutter (50). In addition, or in the alternative, the interiorof cutter (50), defining cutter lumen (52), may be subject to acidetching and/or plasma etching to reduce adhesion between tissue andcutter (50). In addition, or in the alternative, a hydrolubricousmaterial or other non-stick coating may be applied to the interior ofcutter (50), defining cutter lumen (52), to reduce friction betweentissue and cutter (50). In addition, or in the alternative, the interiorof cutter (50), defining cutter lumen (52), may be subject to a riflingsurface cut. Other suitable treatments for the interior of cutter (50)will be apparent to those of ordinary skill in the art in view of theteachings herein. Alternatively, the interior of cutter (50) may besubject to no treatment at all in some embodiments.

In an alternate embodiment of cutter (50), a distal portion of cutter(50) has an inner diameter and outer diameter that are less than theinner diameter and outer diameter of a proximal portion of cutter (50).For instance, the distal-most inch of cutter (50) may provide a neckdown region (not shown), which transitions into a region having agreater diameter along the remaining, proximal length of cutter (50).Such a neck down configuration may reduce tissue compression as a tissuesample (4) moves proximally through cutter lumen (52). The distal end ofouter cannula (12) may also have a complimentary neck down region thatis either the same length as, shorter than, or longer than a neck downregion of cutter (50). Other suitable lengths of a neck down region incutter (50) and/or outer cannula (12) will be apparent to those ofordinary skill in the art in view of the teachings herein.

In another alternative embodiment of cutter (50), a plurality of raisedsurfaces are provided, extending inwardly within the interior of cutter(50), running the length of cutter (50). Such raised surfaces may beconfigured to reduce tissue surface contact with the interior of cutter(50).

In yet another alternative embodiment of cutter (50), an inner sleeve(not shown) may be provided within the distal end interior of cutter(50). For instance, such an inner sleeve may have a length ofapproximately 0.15 inches or any other suitable length. The distal endof cutter (50) may be chamfered after such an inner sleeve is inserted,such that chamfered cutter (50) end and the chamfered sleeve endcollectively provide a sharp edge for severing tissue. As a severedtissue sample (4) travels proximally through cutter lumen (52), it willencounter a greater inner diameter of cutter lumen (52) as soon as thetissue sample (4) passes the proximal end of the inner sleeve. Thisincrease in effective diameter may reduce compression of the tissuesample (4), thereby improving transport reliability of the tissue sample(4). Still other suitable variations of cutter (50) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

C. Exemplary Needle Hub

As shown in FIGS. 12-13, a needle hub (60) is secured to outer cannula(12), and comprises a thumbwheel (62) and a sleeve portion (64)extending proximally from thumbwheel (62). Needle hub (60) of thepresent example is overmolded about a proximal portion of outer cannula(12), though needle hub (60) may be formed and/or secured relative toouter cannula (12) using any other suitable techniques (e.g., setscrews, adhesives, etc.). Furthermore, while needle hub (60) of thepresent example is formed of a plastic material, any other suitablematerial or combination of materials may be used.

Sleeve portion (64) of the present example comprises an annularprojection (66), a longitudinal slot (68), and a transverse opening(70), which is formed near the proximal end of sleeve portion (64). Oneor more additional transverse openings (70) (e.g., diametrically opposedtransverse openings (70)) may also be provided in sleeve portion (64). Apair of o-rings (72) are positioned such that one o-ring (72) isproximal to transverse opening (70) and another o-ring (72) is distal totransverse opening (70). As will be described in greater detail below,transverse opening (70) is in fluid communication with the interiordefined by needle hub (60), which is also in fluid communication withvacuum lumen (40) of outer cannula (12). Other suitable configurationsfor sleeve portion (64) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

Thumbwheel (62) is operable to rotate outer cannula (12) about itslongitudinal axis, relative to cover member (114) and base member (116).For instance, thumbwheel (62) may be used to orient aperture (16) to anumber of desired orientations about the longitudinal axis defined byouter cannula (12). Such multiple orientations may be desirable, by wayof example only, to obtain a plurality of tissue samples (4) from abiopsy site, without requiring the needle portion (10) to be removedfrom the patient during the acquisition of such a plurality of tissuesamples (4). An illustrative example of such rotation and acquisition ofmultiple tissue samples (4) is disclosed in U.S. Pat. No. 5,526,822, thedisclosure of which is incorporated by reference herein. Other ways inwhich multiple tissue samples (4) may be obtained at various locationswill be apparent to those of ordinary skill in the art in view of theteachings herein. For instance, rotation of outer cannula (12) may bemotorized or automated, such as using any of the components described ingreater detail below, or using any other suitable components ortechniques. As another non-exhaustive example, an entire biopsy device(101) may be rotated during acquisition of tissue samples (4), withoutnecessarily removing biopsy device (101) from the patient during suchrotation and tissue sample (4) acquisition, to obtain tissue samples (4)from various orientations about the longitudinal axis defined by outercannula (12).

It will also be appreciated that other structures may be used to performmanual rotation of outer cannula (12). In particular, and as shown inFIG. 12-13, an exposed gear (74) may be engaged with outer cannula (12).In this example, gear (74) is slid onto the proximal end of sleeveportion (64). A radially inwardly extending projection (not shown) ofgear (74) is configured to mate with slot (68) of sleeve portion (64),such that gear (74) rotates unitarily with sleeve portion (64) whilebeing movable longitudinally along sleeve portion (64). With sleeveportion (64) being unitarily engaged with outer cannula (12), rotationof gear (74) will further cause rotation of cannula (12) for reorientingaperture (16). Gear (74) is further configured to engage with acomplimentary exposed gear (206) of holster (202), as will be describedin greater detail below. In particular, gear (74) is configured to meshwith gear (206) such that gear (206) can impart rotation to gear (74),thereby rotating outer cannula (12). Some exemplary structures andtechniques for selectively causing gear (206) to rotate will bediscussed in greater detail below, while others will be apparent tothose of ordinary skill in the art in view of the teachings herein.

It will also be appreciated in view of the teachings herein that theorientation of aperture (16) may be indicated on a graphical userinterface. For instance, one or more sensors may be operable to detectthe orientation of aperture (16), and communicate indicative data to aprocessor. The processor may be in communication with a display (e.g.,display screen (702), described below, etc.) to provide visualindication of aperture (16) orientation. Other ways in which theorientation of aperture (16) may be indicated to a user will be apparentto those of ordinary skill in the art in view of the teachings herein.Alternatively, orientation of aperture (16) may be not indicated to auser.

D. Exemplary Needle Manifold

As shown in FIG. 12, a needle manifold (80) is provided about sleeveportion (64). Needle manifold (80) is fixed relative to base member(116) in this example. Needle manifold (80) is in fluid communicationwith tube (402), such that tube (402) may communicate saline, a vacuum,atmospheric air, and/or pressurized air, etc., to needle manifold (80),as will be described in greater detail below. Needle manifold (80) isfurther in fluid communication with the interior of sleeve portion (64),via transverse opening (70). O-rings (64) are configured to maintain afluid seal between needle manifold (80) and sleeve portion (64), even assleeve portion (64) translates longitudinally relative to needlemanifold (80), such as during firing of needle (10) as will be describedin greater detail below; and even during rotation of sleeve portion (64)about its longitudinal axis. A seal (not shown) is also provided at theproximal end of sleeve portion (64), at the interface between sleeveportion (64) and cutter (50). Needle manifold (80), sleeve portion (64),and outer cannula (12) are thus configured and arranged such thatsaline, a vacuum, atmospheric air, and/or pressurized air, etc. that iscommunicated via tube (402) to needle manifold (80) will be communicatedto vacuum lumen (40) via transverse opening (70). Of course, any othersuitable structures or arrangements may be used to communicate saline, avacuum, atmospheric air, and/or pressurized air, etc. from tube (402) tovacuum lumen (40).

E. Exemplary Cutter Rotation and Translation Mechanism

In the present example, and as shown in FIG. 14, body portion (112) ofprobe (102) comprises a cutter rotation and translation mechanism (120),which is operable to rotate and translate cutter (50) within outercannula (12). Cutter rotation and translation mechanism (120) comprisesa sleeve (122) unitarily secured to cutter (50), a nut member (124), anda gear (138). In the present example, sleeve (122) is formed of plasticovermolded about cutter (50), though any other suitable materials may beused, and sleeve (122) may be secured relative to cutter (50) using anyother suitable structures or techniques (e.g., set screws, etc.). Nutmember (124) is secured relative to base member (116), and has internalthreads (126). A portion of sleeve (122) has external threads (128) thatare configured to engage with threads (126) of nut member (124). Threads(126, 128) are configured such that, as sleeve (122) rotates relative tonut member (124), sleeve (122) will longitudinally translate relative tonut member (124), depending on the direction of such relative rotation.By way of example only, threads (126, 128) may be configured to have apitch that provides approximately 40-50 threads per inch. Such a threadpitch may provide a ratio of cutter (50) rotation to cutter (50)translation that is ideal for severing tissue. Alternatively, any otherthread pitch may be used. With sleeve (122) being unitarily secured tocutter (50) in the present example, longitudinal translation of sleeve(122) relative to nut member (124) will result in the same translationof cutter (50).

Another portion of sleeve (122) has a plurality of external flats (130),which are configured to engage with a complimentary plurality ofinternal flats (132) of gear (138). Gear (138) is positioned coaxiallyabout sleeve (122) and cutter (50). Flats (130, 132) are configured suchthat rotation of gear (138) causes rotation of sleeve (122). With sleeve(122) being unitarily secured to cutter (50) in the present example,rotation of gear (138) and sleeve (122) will result in the same rotationof cutter (50). Flats (130, 132) are further configured such that sleeve(122) may translate longitudinally relative to gear (138) (e.g., the fitbetween sleeve (122) and gear (138) is not so tight as to prevent suchtranslation). It will therefore be appreciated that, as gear (138)rotates, given the relative configurations of threads (126, 128) andflats (130, 132), such rotation of gear (138) will simultaneously resultin rotation and longitudinal translation of sleeve (122), which will inturn result in simultaneous rotation and longitudinal translation ofcutter (50).

In the present example, gear (138) is partially exposed through basemember (116), and is configured to mate with a complimentary exposedgear (208) of holster (202), as will be described in greater detailbelow. In particular, gear (138) is configured to mesh with gear (208)such that gear (208) can impart rotation to gear (138), therebyactivating cutter rotation and translation mechanism (120). As will bedescribed in greater detail below, gear (208) is in communication with amotor (272) that is within holster (202). In the present example, gears(138, 208) and threads (126, 128) are configured such that eachrevolution of motor (272) results in approximately 0.00012 inches oftranslation of cutter (50). Of course, any of these components may haveother configurations that result in any other suitable ratio of cutter(50) translation to motor (272) rotation.

It will be appreciated in view of the teachings herein that cutterrotation and translation mechanism (120) described above is merelyexemplary, and that translation and/or rotation of cutter (50) mayalternatively be provided in various other ways. For instance, biopsyprobe (102) may include a motor (not shown) or other device, such thatbiopsy probe (102) lacks exposed gear (138). Alternatively, any suitablestructure other than exposed gear (138) (e.g., a rack, etc.) may be usedto receive communication of motion or energy from some other component,in order to rotate and/or translate cutter (15). Furthermore, cutterrotation and translation mechanism (120) may be configured such thatmore than one exposed gear (138) is present (e.g., one gear (138) forreceiving translation motion, and another gear (138) for receivingrotation motion, etc.). In other merely illustrative alternatives,translation and/or rotation of cutter (50) may be performed at least inpart by pneumatic actuators (not shown), pneumatic motors (not shown),or a variety of other components. Furthermore, it will be appreciatedthat pneumatic components may be combined with other mechanicalcomponents and/or electromechanical components in order to translateand/or rotate cutter (50).

Base member (116) further comprises a cutter passage (54), through whichthe proximal end of cutter (50) is disposed. A seal (56) is provided atthe distal interface of cutter (50) and cutter passage (54), to preventescape of a vacuum or fluid between the outer surface of cutter (50) andthe inner surface of the distal end of cutter passage (54). Cutterpassage (54) is sized such that, as cutter (50) translates during use ofbiopsy device (100), the distal end of cutter (50) remains within cutterpassage (54). Of course, any other suitable structures or configurationsmay be used.

F. Exemplary “Sharps Reduction” Variation

In the present example, needle portion (10) and cutter (50) areconfigured to be removable from biopsy probe (102), such as after asession of use of biopsy device (100). In particular, base member (116)of body portion (112) of biopsy probe (102) comprises a release tab(118), which is resiliently movable relative to base member (116) via anarm (119). Release tab (118) is configured to restrict axial movement ofneedle portion (10) by restricting axial movement of gear (74), which isengaged with sleeve portion (64) of hub (60) as noted above, whenrelease tab (118) is in a default position. Of course, the engagementbetween and configurations of gear (74) and sleeve portion (64) willpermit some degree of axial movement of needle portion (10), such as forfiring of needle portion (10), even while release tab (118) is in adefault position. However, when release tab (118) is sufficientlydepressed, such as by a user, release tab will provide clearance forgear (74) to be moved distally of base member (116). In other words,with release tab (118) sufficiently depressed, the entirety of needleportion (10), including the entirety of needle hub (60) and gear (74),may be axially pulled distally from body portion (112) of biopsy probe(102); such that the entirety of needle portion (10), including theentirety of needle hub (60) and gear (74), may be completely separatedfrom body portion (112).

It will be appreciated in view of the disclosure herein that, with theentirety of needle portion (10), including the entirety of needle hub(60) and gear (74), completely separated from body portion (112), cutter(50) will still be extending from body portion (112). To remove cutter(50) from body portion, a user may simply “unscrew” cutter (50) frombody portion (112). In particular, the user may grip a portion of needle(50) protruding from body portion (112) and rotate needle (50) relativeto body portion (112) while pulling distally on cutter (50). Suchrotation and pulling of cutter (50) may cause interaction of threads(126, 128) that ultimately results in threads (128) passing completelydistally past threads (126). With threads (128) passing completelydistally past threads (126), no other components of body portion (112)will substantially constrain cutter (50) in the axial direction, suchthat cutter (50) may be pulled distally completely from body portion(112) without further rotation. In other words, after sufficientrotation of cutter (50) relative to body portion (112), cutter (50) maybe completely separated from body portion (112). It will be appreciatedin view of the teachings herein that sleeve (122) and needle manifold(80) may be configured such that sleeve (122) may be axially passedcompletely through needle manifold (80). Gear (138) may essentiallyremain in its place as sleeve (122) and the rest of cutter (50) ispulled axially relative thereto. Other suitable relationships betweencomponents to provide, permit, or facilitate removability of needleportion (10) and cutter (50) from body portion (112) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

While a release tab (118) and other components have been described asproviding and/or permitting complete removability of needle portion (10)and cutter (50) from body portion (112), it will be appreciated in viewof the teachings herein that such removability may be provided using avariety of other structures and techniques. For instance, in someembodiments, tab (118) or some other feature is configured to break awayfrom base member (116) when engaged with sufficient force, permittingremoval of the entirety of needle portion (10), including the entiretyof needle hub (60) and gear (74). In yet another alternate embodiment,probe (102) is configured such that, when needle portion (10) and needlehub (60) are manually angulated relative to rest of body portion (112),a retention feature located in base member (116) is disengaged, allowingthe entirety of needle portion (10), including the entirety of needlehub (60) and gear (74), to be removed axially from body portion (112).Still other components, features, and techniques for providing,permitting, or facilitating removability of needle portion (10) andcutter (50) from body portion (112) will be apparent to those ofordinary skill in the art in view of the teachings herein.

It will also be appreciated that such removability may reduce the amountof “sharps” provided by biopsy device (100). In particular, to theextent that sharp device components that have been exposed to bodilyfluids need to be disposed of in a manner different from disposal ofother waste (e.g., placed in a “sharps bin” as opposed to a regulartrash bin), the complete removability of needle portion (10) and cutter(50) from body portion (112) may permit the needle portion (10) andcutter (50) to be handled in accordance with “sharps” waste disposalprocedure without requiring the remainder of body portion (112) to besubject to the same waste disposal. In other words, and by way ofexample only, after a use of biopsy device (100), the needle portion(10) and cutter (50) may be removed from body portion (112) and placedin a “sharps bin,” while the remainder of body portion (112) may beplaced in a regular trash bin.

G. Exemplary Tissue Sample Holder Manifold

As shown in FIGS. 15-19, a tissue sample holder (140) is provided at theend of body portion (112) of probe (102). Tissue sample holder (140)comprises a cup (142), a manifold (144), and a plurality of trays (160).Manifold (144) includes a central recess (146), a plurality oflongitudinal passages (148), a plurality of chambers (150) defined byradially extending walls (152), and plurality of radial passages (154).Each longitudinal passage (148) is substantially in fluid isolationrelative to every other longitudinal passage (148). However, each radialpassage (154) is substantially in fluid communication with every otherradial passage (154) via an annular passage (not shown) located withinthe rear of manifold (144). Alternatively, each radial passage (154) maybe substantially in fluid isolation relative to every other radialpassage (154). In the present example, each longitudinal passage (148)is in fluid communication with a corresponding one of each radialpassage (154). In particular, each longitudinal passage (148) terminatesproximally in a corresponding radial passage (154).

In addition, each radial passage (154) is in fluid communication with acorresponding one of each chamber (150), via a respective pair ofopenings (156). Accordingly, it will be appreciated that eachlongitudinal passage (148) is in fluid communication with acorresponding chamber (150), via a corresponding radial passage (154)and pair of openings (156). In particular, the radial position of eachlongitudinal passage (148) relative to central recess (146) correspondswith the radial position of the associated radial passage (154), pair ofopenings (156), and chamber (150). Of course, any other suitablestructures or configurations for manifold (144) may be used.

In some variations, a screen, mesh, or other component is provided on orin manifold (144), or elsewhere within tissue sample holder (140), toprevent passage of tissue into or through certain openings or gaps. Inother variations, such components are omitted.

H. Exemplary Tissue Sample Trays

Trays (160) of the present example are configured to be placed onmanifold (144), and to receive tissue samples (4) as will be describedin greater detail below. Each tray (160) may be rigid, and may bepreformed to have a generally arcuate configuration. Alternatively,trays (160) may be formed of a flexible material, such that trays (160)may be bent to conform to the curvature of manifold (144).Alternatively, trays (160) may comprise one or more joints, such thatportions of trays (160) may bend or flex at such joints. Still othersuitable configurations may be used.

Each tray (160) of the present example has a base portion (162) and aplurality of hollow wall portions (164). Hollow wall portions (164)define chambers (166). By way of example only, each chamber (166) may beconfigured to receive a single tissue sample (4) captured by cutter(50). Alternatively, chambers (166) may be configured such that eachchamber (166) may hold more than one tissue sample (4). Manifold (144)and chambers (166) of the present example are further configured suchthat blood, saline, and/or other fluids may pass through a chamber (166)and exit through tube (404), even if a tissue sample (4) is within sucha chamber (166). In other words, chamber (166) will permit fluids topass around a tissue sample (4).

As shown, the underside of each hollow wall portion (164) is configuredto receive a wall (152) of manifold (144). Wall portions (164) and walls(152) are configured such that a gap is provided between each baseportion (162) and manifold (144) when trays (160) are placed on manifold(144). As is also shown, each hollow wall portion (164) has a generallytapered configuration, though any other suitable configuration may beused. In addition, trays (160) have a plurality of openings (168) thatare formed, in sets, through the base portion (162) within each chamber(164). Accordingly, each chamber (166) of trays (160) is in fluidcommunication with an associated chamber (150) of manifold (144) viaopenings (168). Each longitudinal passage (148) of manifold (144) istherefore in fluid communication with a corresponding chamber (166) oftrays (160). It will therefore be appreciated that, when tube (404) isplaced in fluid communication with a given longitudinal passage (148),tube (404) will be in fluid communication with the chamber (166) that isassociated with that longitudinal passage (148).

In the present example, manifold (144) and trays (160) provide eighteenchambers (150, 166). Alternatively, any other number of chambers (150,166) (i.e., more or less than eighteen) may be provided. For instance,in one variation, manifold (144) provides three chambers (150), andthree trays (160) are used that each have only one chamber (166). In yetanother variation, a single tray (160) is used. For instance, a singletray (160) may provide a single large chamber (166) or any suitablenumber of chambers (166). Other suitable numbers of chambers (150, 166)and ways in which such chambers (150, 166) may be provided will beapparent to those of ordinary skill in the art in view of the teachingsherein. Furthermore, manifold (144) and trays (160) may have anysuitable shape.

Each tray (160) may further comprise one or more types of markings orother indicia to distinguish one chamber (166) from another chamber(166). For instance, a number or other distinguishing marking may beprovided on or near each chamber (166), such as in relief form, inrecessed form, or otherwise. In another embodiment, a radiopaque markeris provided on or near each chamber (166). For instance, an entire tray(160) that is carrying one or more tissue samples (4) may be placedunder X-ray for evaluation, and the radiopaque marker associated witheach chamber (166) (and hence, associated with each tissue sample (4)),may be visible in the image obtained using X-ray. In other words, tissuesamples (4) need not necessarily be removed from trays (160) in order totake an X-ray or radiograph image of tissue samples (4). Furthermore,trays (160) may be dropped directly into formalin or any other liquidwith tissue samples (4) still on trays (160). In addition, trays (160)may be placed in a sleeve or container, etc., individually or in groups,to protect tissue samples (4) and/or to ensure that tissue samples (4)stay in trays (160) or for other purposes. Such a sleeve or containermay be flexible, rigid, or have other properties. By way of exampleonly, a sleeve or other container may be flat, and may be configured toflatten out a flexible tray (160) that is inserted therein. Otherstructures and techniques that may be used with trays (160), such asafter tissue samples (4) are communicated to trays (160) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Cup (142) is configured to engage bayonets (134) of base member (116),such that cup (142) may be removed from or secured to base member (116)upon sufficient rotation of cup (142) relative to base member (116). Inaddition, an o-ring (136) is provided about base member (116) to providea seal between base member (116) and cup (142). Of course, any othersuitable structures may be used to provide engagement of cup (142) withbase member (116) and/or to provide a seal between base member (116) andcup (142). Cup (142) is also formed of a transparent material in thepresent example, enabling the user to visually inspect tissue samples(4) in tissue sample holder (140) while tissue sample holder (140) isstill coupled with base member (116). For instance, a user may inspecttissue samples (4) for color, size, and density (e.g., to the extentthat chamber (166) is full of saline, etc.).

It will also be appreciated in view of the teachings herein that theremovability of cup (142) and trays (160) may permit a user to harvest arelatively large number of tissues samples in a relatively short periodof time. Furthermore, the removability of cup (142) and trays (160) maypermit a user to remove unsatisfactory tissue samples (4) from tissuesample holder (140) (e.g., using tweezers, etc.) and then re-coupletrays (160) and cup (142) for further sampling. Other ways in which theremovability and other properties of tissue sample holder (140) of thepresent example may be utilized will be apparent to those of ordinaryskill in the art in view of the teachings herein.

I. Exemplary Rotation and Alignment of Manifold

Manifold (144) of the present example is configured to rotate relativeto base member (116), as will be described in greater detail below.Manifold (144) of the present example is further configured such thateach longitudinal passage (148) may be selectively aligned with a port(406) that is in fluid communication with tube (404). Such alignment ofa longitudinal passage (148) and port (406) will place the alignedlongitudinal passage (148) in fluid communication with tube (404), suchthat induction of a vacuum within tube (404) will effect induction of avacuum within longitudinal passage (148), as well as within the chamber(166) associated with that longitudinal passage (148). In addition,manifold (144) and trays (160) of the present example are configuredsuch that each chamber (166) may be selectively placed in fluidcommunication with cutter lumen (52). It will therefore be appreciatedthat a vacuum in tube (404) may induce a vacuum in cutter lumen (52),with the vacuum being communicated via port (406), an associatedlongitudinal passage (148), an associated radial passage (154), anassociated pair of openings (156), an associated chamber (150), anassociated set of openings (168), and an associated chamber (166). Ofcourse, there are a variety of other ways in which a vacuum may beinduced within a cutter lumen (52), and any other suitable structures ortechniques may be used. Furthermore, pressurized air, a liquid (e.g.,saline), or any other fluid may be communicated in either directionthrough the above-mentioned components in lieu of or in addition to avacuum being induced therein.

A gear (170) is engaged with manifold (144) of the present example. Inparticular, gear (170) has a shaft (172) that is inserted within centralrecess (146) of manifold (144). The shaft (172) has a flat (174) that isconfigured to engage a complimentary flat (147) of central recess (146).Engagement of flats (174, 147) is such that gear (170), shaft (172), andmanifold (144) rotate unitarily. Alternatively, gear (170) and manifold(144) may have any other suitable configurations or relationships.Nevertheless, gear (170) of the present example may be used to rotatemanifold (144), which will in turn permit selective alignment oflongitudinal passages (148) with port (406), in addition tocontemporaneously permitting selective alignment of chambers (166) withcutter lumen (52). In particular, and as will be described in greaterdetail below, gear (170) is configured to mesh with a complimentary gear(210) of holster (202), such that gear (210) may be used to impartrotation to gear (170). Such rotation may be used to selectively (e.g.,consecutively) align chambers (166) with cutter lumen (52), tosuccessively collect a discrete tissue sample (4) in each chamber (166)during use of biopsy device (100). Furthermore, such collection oftissue samples (4) may be performed without having to withdraw andre-insert needle portion (10) relative to patient during such a process.

J. Exemplary “Parking Pawl”

Body portion (112) of the present example further comprises anengagement member (180), which is secured to base member (116). As shownin FIG. 20, engagement member (180) comprises a pawl portion (182)having teeth (184). Pawl portion (182) is resiliently urged for teeth(184) to engage with gear (170). In particular, engagement of teeth(184) of pawl portion (182) with gear (170) prevents rotation of gear(170) (and hence, prevents rotation of manifold (144)). Accordingly,pawl portion (182) is configured to prevent rotation of manifold (144)when pawl portion (182) is in a default position. In the presentexample, pawl portion (182) is in the default position when biopsy probe(102) is not coupled with a holster (202). However, when biopsy probe(102) is coupled with a holster (202), a boss (212) on holster (202) isconfigured to engage pawl portion (182). In particular, boss (212) onholster (202) is configured to disengage pawl portion (182) from gear(170) when biopsy probe (102) is coupled with a holster (202), such thatpawl portion (182) will no longer prevent rotation of gear (170) ormanifold (144) when biopsy probe (102) is coupled with a holster (202).When biopsy probe (102) is removed from holster (202), the resilience ofengagement member (180) urges pawl portion (182) back to the defaultposition, such that pawl portion (182) will again prevent rotation ofgear (170) and manifold (144).

When biopsy probe (102) is packaged for shipment from a manufacturingfacility, or in other situations, tissue sample holder (140) may beconfigured such that a predetermined chamber (166) is aligned withcutter lumen (52). With pawl portion (182) maintaining such alignment tothe time when biopsy probe (102) is coupled with a holster (202) for afirst use, software or control logic that is used to control biopsydevice (100) may “safely assume” that the predetermined chamber (166) isaligned with cutter lumen (52), and may control biopsy device (100)accordingly. Furthermore, if biopsy probe (102) is removed from holster(202) during a tissue sample (4) acquisition procedure, software orcontrol logic that is used to control biopsy device (100) may “remember”which chamber (166) was last aligned with cutter lumen (52), to theextent that software tracks which chamber (166) is being or has beenused during a procedure. If biopsy probe (102) is recoupled with holster(202) to continue the procedure, the software or control logic maycontinue to control biopsy device (100) based on the chamber (166) thatthe software “remembered.” Alternatively, a user may specify that a newbiopsy probe (102) has been coupled with holster (202), which may resultin the software or control logic again “assuming” that the predeterminedchamber (166) is the one that is aligned with the cutter lumen (52).

While a pawl portion (182) has been described as a structure selectivelypreventing the rotation of gear (170) and manifold (144), it will beappreciated that any other alternative structures may be used for suchpurposes. By way of example only, a Geneva wheel mechanism (not shown)may be used as an alternative mechanism for rotating manifold (144) andmaintaining the rotational position of manifold (144) betweenintentional rotations. For instance, gear (170) may be substituted witha Geneva driven wheel (not shown), while gear (210) may be substitutedwith a Geneva drive wheel (not shown). Other suitable alternatives forrotating manifold (144) and/or maintaining the rotational position ofmanifold (144) will be apparent to those of ordinary skill in the art inview of the teachings herein. In addition, it will be appreciated that abiopsy device (100) may lack a pawl portion (182) or other rotationprevention feature altogether, such that a manifold (144) may freelyrotate when biopsy probe (102) is not coupled with a holster (202).

K. Exemplary Dedicated Passage

As shown in FIGS. 16-17, 19, and 21, tissue sample holder (140) of thepresent example has a passage (158) formed through manifold (144).Passage (158) extends longitudinally, completely through manifold (144),and is offset from but parallel with the central axis defined bymanifold (144). Like chambers (166), passage (158) is configured to beselectively aligned with cutter lumen (52). However, unlike chambers(166), passage (158) is not in fluid communication with any oflongitudinal passages (148) or radial passages (154). In other versions,passage (158) may be provided in fluid communication with one or morelongitudinal passages (148) and/or radial passages (154).

Passage (158) of the present example is configured to permit instrumentsand/or liquids, other materials, etc., to be passed through manifold(144) and through cutter lumen (52). For instance, passage (158) may beused to insert an instrument for deploying one or more markers at abiopsy site, via cutter lumen (52) and via outer cannula (12), outthrough aperture (16). A merely exemplary marker applier that may beinserted through passage (158) may include the MAMMOMARK biopsy sitemarker applier, by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Othersuitable marker applier devices that may be inserted through passage(158) may include any of those described in U.S. Pat. No. 7,047,063;U.S. Pat. No. 6,996,433; U.S. Pat. No. 6,993,375; or U.S. Pub. No.2005/0228311, the disclosure of each of which is incorporated byreference herein. Any of such appliers, including variations of thesame, may be introduced through passage (158) to deploy one or moremarkers at a biopsy site, via aperture (16), while needle portion (10)remains inserted in a patient (e.g., shortly after biopsy samples areextracted from the patient, etc.). Such marker deployment may beaccomplished even while tissue samples (4) reside within tissue sampleholder (140), secured to biopsy probe (102). Alternatively, such markerappliers may be inserted directly into cutter lumen (52) with tissuesample holder (140) being removed from biopsy probe (102).

As noted above, biopsy probe (102) may be initially provided with apredetermined chamber (166) being aligned with cutter lumen (52) bydefault. However, in other versions, biopsy probe (102) is initiallyprovided with passage (158) being aligned with cutter lumen (52) bydefault. Furthermore, to the extent that a user desires having passage(158) aligned with cutter lumen (52) during use of biopsy device (100),after manifold (144) has been rotated during such use, the controls maybe used to command manifold (144) to rotate to align passage (158) withcutter lumen (52).

Cup (142) further comprises an opening (176) and a hatch (178). Opening(176) is configured to be aligned with passage (158) when cup (142) issecured to base member (116), such as by rotating manifold (144) toalign passage (158) with opening (176). Hatch (178) is configured toselectively cover opening (176). For instance, hatch (178) may beconfigured to seal opening (176) when hatch (178) covers opening (176).Hatch (178) may further be configured to permit a user to “peel back”hatch (178) and/or pivot hatch (178) in order to gain access to opening(176) and passage (158). It will be appreciated in view of thedisclosure herein that hatch (178) may be substituted or supplementedwith a variety of alternative structures, including but not limited to aremovable stopper or other structure.

L. Exemplary Medicine Applier

As shown in FIGS. 21-22, an applier (90) may be coupled with biopsyprobe (102) via opening (176) in cup (142) and passage (158) in manifold(144). In this example, applier (90) comprises a hollow shaft portion(92) and a luer lock portion (94). Shaft portion (92) is sized andconfigured such that, when applier (90) is inserted through opening(176) and through passage (158), shaft portion (92) creates a seal withcutter lumen (52) (e.g., through engagement with the inner surface ofcutter lumen (52)). Shaft portion (92) and luer lock portion (94) maythereby be placed in fluid communication with cutter lumen (52). By wayof example only, a syringe (not shown) or other device may be coupledwith luer lock portion (94). A therapeutic agent may thus be injectedfrom such a syringe, through applier (90), through cutter lumen (52),through outer cannula (12), and out through aperture (16) to reach abiopsy site. Such injections may be made before or after tissue samples(4) are acquired using biopsy device (100), and may be made while needleportion (10) remains inserted in the patient. Other suitable ways inwhich an applier (90) may be used, as well as alternative ways in whichan applier (90) may be configured, will be apparent to those of ordinaryskill in the art in view of the teachings herein. By way of exampleonly, applier (90) may alternatively be inserted directly into cutterlumen (52) with tissue sample holder (140) being removed from biopsyprobe (102).

II. Exemplary Holster for Stereotactic Use

As shown in FIGS. 23-32, a holster (202) comprises a top cover (204),through which a portion of each of gears (206, 208, 210) is exposed,side panels (214, 216), and a base member (218). As described above,boss (212) is provided on top cover (204), and is configured todisengage pawl portion (182) from gear (170) when biopsy probe (102) iscoupled with holster (202). Holster (202) of this example furthercomprises a needle rotation mechanism (220), a needle firing mechanism(240), a cutter drive mechanism (270), and a tissue holder rotationmechanism (280). In addition, a user interface (800) is provided on eachside panel (214, 216). Each of these merely exemplary components will bedescribed in greater detail below.

As noted above, holster (202) of the present example is configured to becoupled with a biopsy probe (102), such as biopsy probe (102) describedabove, to provide a biopsy device (100). In addition, holster (202) isconfigured to be mounted to a table, fixture, or other device, such asfor use in a stereotactic or X-ray setting. However, it will beappreciated in view of the disclosure herein that holster (202) may beused in a variety of other settings and combinations.

A. Exemplary Needle Rotation Mechanism

In the present example, and as shown in FIG. 27, needle rotationmechanism (220) comprises a pair of knobs (222), each of which has arespective gear (224) in beveled engagement with a gear (226) on theproximal end of an elongate shaft (228). Another gear (not shown), whichis provided on the distal end of shaft (228), is engaged with gear(230). Gear (230) is engaged with yet another gear (232) on the proximalend of yet another shaft (234). The distal end of shaft (234) hasanother gear (236), which is engaged with gear (206) described above. Itwill therefore be appreciated in view of the disclosure herein thatrotation of one or both of knobs (222) will result in rotation of gear(206), with such rotation being communicated via gears (224, 226, 230,236) and shafts (228, 234). Furthermore, as also noted above, whenbiopsy probe (102) is coupled with holster (202), gear (206) will meshwith gear (74). Thus, when biopsy probe (102) is coupled with holster(202), rotation of one or both of knobs (222) will cause needle portion(10) of biopsy probe (102) to rotate. Of course, a variety ofalternative mechanisms, structures, or configurations may be used as asubstitute or supplement for needle rotation mechanism (220). By way ofexample only, a motor (not shown) may be used to effect rotation ofneedle portion (10). In other versions, needle rotation mechanism (220)may simply be omitted altogether.

B. Exemplary Needle Firing Mechanism

As shown in FIGS. 28-29, needle firing mechanism (240) of the presentexample comprises a pair of triggers (242), buttons (244), a motor(246), a firing rod (248), and a fork (250). Fork (250) is configured toengage sleeve portion (64) of needle hub (60) when biopsy probe (102) iscoupled with holster (202). For instance, fork (250) may engage sleeveportion (64) between thumbwheel (62) and annular projection (66). In thepresent example, engagement between fork (250) and sleeve portion (64)is such that sleeve portion (64) (and therefore, needle portion (10))will translate longitudinally with fork (250). Fork (250) is coupledwith firing rod (248), such that fork (250) will translatelongitudinally with firing rod (248).

A damper (252) with a washer (253) is provided about firing rod (248). Acoil spring (254) is also provided about firing rod (248). Inparticular, coil spring (254) is engaged with both washer (253) and aportion of base member (218). Coil spring (254) is biased to urge damper(252), washer (253), and firing rod (248) distally. It will beappreciated, however, that like other components described herein, coilspring (254) is merely exemplary, and a variety of alternativecomponents (resilient or otherwise) may be used in addition to or inlieu of coil spring (254).

A sled (256) and a screw gear (258) are also coupled with firing rod(248). In particular, sled (256) is coupled with the proximal end offiring rod (248), and is configured to longitudinally translateunitarily with firing rod (248). Similarly, screw gear (258) isconfigured to longitudinally translate with firing rod (248) (through atleast some range of motion), while being prevented from rotating aboutfiring rod (248). An outer gear (260) is engaged with screw gear (258).In particular, the interior (not shown) of outer gear (260) is engagedwith the threads of screw gear (258); such that when outer gear (260)rotates relative to screw gear (258), such rotation causes screw gear(258) to longitudinally translate relative to outer gear (260). Outergear (260) is in communication with another gear (262), which is itselfin communication with a gear (264) that is coupled with motor (246).Accordingly, when motor (246) is activated to rotate, such rotation willcause screw gear (258), firing rod (248), and sled (256) tolongitudinally translate. In other words, rotation of motor (246) willbe communicated to outer gear (260) via gears (262, 264), and suchrotation will be converted to longitudinal motion due to theconfiguration and engagement of outer gear (260) and screw gear (258).Of course, all of these components are merely illustrative, and anyother suitable components, configurations, or techniques may be used tocause longitudinal translation of firing rod (248).

Triggers (242) of the present example are each configured to partiallyrotate forward and rearward, while buttons (244) are configured to bepressed inward. In addition, a plurality of switches (not shown) may becommunicatively coupled with triggers (242) and/or buttons (244), suchthat the switches are selectively activated by a user when triggers(242) are moved forward or rearward and/or when buttons (244) aredepressed. One or more resilient members (e.g., a spring, etc.) may beincluded to bias each trigger (242) to a centered or substantiallyvertical orientation. One or more resilient members (e.g., a spring,etc.) may also be included to bias each button (244) to an outwardposition. Triggers (242) and buttons (244) are also sealed in thepresent example to prevent ingress of fluid into holster (202), thoughlike other features, this is merely optional.

In the present example, triggers (242) are further configured such that,when one or both of triggers (242) are moved rearward, such movementactivates a switch that is in communication with motor (246). Suchactivation causes motor (246) to rotate, which in turn causes firing rod(248) to longitudinally translate proximally as described above. As willbe described in greater detail below, such rearward movement of trigger(242) may thus cause motor (246) to arm or “cock” the needle firingmechanism (240).

Needle firing mechanism (240) of the present example further comprises acatch (266), which is configured to selectively engage sled (256). Inparticular, as firing rod (248) and sled (256) are longitudinallytranslated proximally (e.g., by rotation of motor (246)), sled (256)approaches catch (266). When catch (266) and sled (256) engage, catch(266) is configured to hold sled (256) (and therefore, firing rod (248))in place. Catch (266) may maintain such position of sled (256) evenafter motor (246) has stopped rotating, and even with spring (254)urging sled (256) and firing rod (248) toward a distal position. Whenthese components are in these proximal positions and configurations,needle firing mechanism (240) may be said to be in a “cocked”configuration. A merely exemplary cocked configuration of needle firingmechanism (240) is shown in FIG. 29.

It will be appreciated in view of the teachings herein that, with needlefiring mechanism (240) in such a cocked configuration, fork (250) andneedle portion (10) will be at a proximal, ready-to-fire position. Oneor more components of biopsy device (100) may be configured to providean audio and/or visual indication that the needle firing mechanism (240)is fully cocked. For instance, biopsy device (100) may produce adistinct clicking sound, beep, or other audible signal; and/or agraphical user interface may provide some visual indication that theneedle firing mechanism (240) is cocked.

In addition, holster (202) may further include one or more sensors (notshown) or other feature(s) configured to sense or detect when needlefiring mechanism (240) has been cocked and/or when needle firingmechanism (240) has been fired. For instance, biopsy system (2) may beconfigured such that one or more functions of biopsy system (2) areessentially disabled while needle firing mechanism (240) is cocked,until needle firing mechanism (240) is fired. By way of example only,biopsy system (2) may prevent initiation of a “sample” cycle (describedbelow), initiation of a “clear probe” cycle (described below), or otherfunctions while needle firing mechanism (240) is cocked. Such functionsmay be again permitted after needle firing mechanism (240) has beenfired and after needle (10) has reached a fully fired position.Alternatively, cocking of needle firing mechanism (240) may have noaffect or other affects on one or more functions of biopsy system (2).

In one variation, after sled (256) has been moved into engagement withcatch (266) to cock needle firing mechanism (240), motor (246) mayreverse its rotation. In this variation, a proximal portion of firingrod (248) may have a longitudinal slot or recess (not shown) formedtransversely through or in firing rod (248). Screw gear (258) may havean internal pin or other feature (not shown) that is configured toengage such a slot or other feature of firing rod (248), such that thepin or other feature of screw gear (258) is further configured to bothprevent screw gear (258) from rotating about firing rod (248) and permitscrew gear (258) to translate through some range of motion relative tofiring rod (248). For instance, before needle firing mechanism (240) iscocked, such a pin or other feature of screw gear (258) may bepositioned at or near the proximal end of a longitudinal slot or recessof firing rod (248); such that as motor (246) is activated to translatescrew gear (258) proximally to cock needle firing mechanism (240), thepin or other feature engages firing rod (248) to urge firing rod (248)proximally with screw gear (258). Then, after sled (256) has been movedproximally into engagement with catch (266), motor (246) may reverse itsrotation. Such reversal of motor (246) rotation may translate screw gear(258) distally. The configuration of the slot or other feature of firingrod (248) and the configuration of the pin or other feature of screwgear (258) may permit such distal translation of screw gear (258)relative to firing rod (248), leaving firing rod in a proximal cockedposition. Furthermore, when needle portion (10) is fired as describedbelow, the configuration of the slot or other feature of firing rod(248) and the configuration of the pin or other feature of screw gear(258) may permit firing rod (248) to translate distally relative toscrew gear (258) with relative ease during such firing. Other suitablerelationships between firing rod (248) and screw gear (258) may be used,including but not limited to a variation described below.

When a user is ready to fire needle portion (10), the user may push andhold one or both of triggers (242) forward, and may push one or bothbuttons (244) in while one or both of triggers (242) are held forward.Such actuation of trigger(s) (242) and button(s) (244) may cause catch(266) to release sled (256). Suitable structures and configurations thatmay be used to cause actuation of trigger(s) (242) and button(s) (244)to result in catch (266) releasing sled (256) will be apparent to thoseof ordinary skill in the art in view of the teachings herein. With sled(256) being so released, the resilience of spring (254) may urge damper(252) and washer (253) (and therefore, firing rod (248), fork (250), andneedle portion (10)) distally, thereby firing needle portion (10). Suchdistal motion of needle portion (10) may be relatively sudden, and maybe performed with a force sufficient to penetrate tissue with tip (14)of needle portion (10).

In another variation, motor (246) does not reverse its rotation toadvance screw gear (258) back to a distal position before needle portion(10) is fired. For instance, screw gear (258) may be unitarily securedto firing rod (248), and may be unable to translate longitudinally ineither direction through any range of motion relative to firing rod(248). In this variation, as needle portion (10) is fired, gears (260,262, 264) may be configured to rotate freely, thereby providingnegligible resistance to distal motion of firing rod (248).Alternatively, a clutch mechanism (not shown) may be provided todisengage one or more of gears (260, 262, 264) during firing of needleportion (10). Other ways in which a needle firing mechanism (240) may beconfigured or operated will be apparent to those of ordinary skill inthe art in view of the teachings herein.

In the present example, triggers (242) and buttons (244) are configuredsuch that pushing or actuation of buttons (244) will have no firingeffect unless triggers (242) are held forward. Similarly, holding oftriggers (242) will not cause firing of needle portion (10) untilbuttons (244) are also pressed while triggers (242) are held forward.Suitable structures and configurations for providing suchinterdependence of triggers (242) and buttons (244) will be apparent tothose of ordinary skill in the art. For instance, buttons (244) mayrotate with triggers (242), such that buttons (244) rotate forward withtriggers (242). In such versions, buttons (244) and catch (266) may beconfigured such that actuation of buttons (244) will not cause catch(266) to release sled (256) unless buttons (244) are rotated forward. Inaddition or in the alternative to buttons (244) rotating with triggers(242), triggers (242) may be configured to lock catch (266) in place(e.g., even with buttons (244) being actuated) until triggers (242) arerotated forward, such that forward rotation of triggers (242) willpermit catch (266) to be released when buttons (244) are actuated. Otherways in which triggers (242) and buttons (244) may be provided asinterdependent for purposes of firing (or for other purposes) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

C. Exemplary Cutter Drive Mechanism

As shown in FIG. 30, cutter drive mechanism (270) of the present examplecomprises a motor (272) with a shaft (274) extending therefrom. Gear(208) is mounted to shaft (274), and is configured to rotate unitarilytherewith. As noted above, a portion of gear (208) is exposed throughtop cover (204), such that gear (208) meshes with gear (138) of cutterrotation and translation mechanism (120) when biopsy probe (102) iscoupled with holster (202). Accordingly, when motor (272) is activatedto rotate, such rotation may be communicated via shaft (274) and gears(208, 138), to effect simultaneous rotation and translation of cutter(50) as described above. Other ways in which a cutter drive mechanism(270) may be configured or operated will be apparent to those ofordinary skill in the art in view of the teachings herein.

D. Exemplary Tissue Holder Rotation Mechanism

As shown in FIGS. 31-32, tissue holder rotation mechanism (280) of thepresent example comprises a motor (282) having a shaft (284) with a gear(286) mounted thereto, such that gear (286) rotates unitarily with shaft(284). Gear (286) is configured to mesh with gear (288), which ismounted to shaft (290). Gear (210), which has been noted above, is alsomounted to shaft (290), at the proximal end of shaft (290). Inparticular, gear (210) is configured to mesh with gear (170) of tissuesample holder (140) when biopsy probe (102) is coupled with holster(202). Accordingly, when motor (282) is activated to rotate, suchrotation may be communicated via shafts (284, 290) and gears (286, 288,210, 170), to effect rotation of manifold (144) as described above.

In addition, an encoder wheel (292) is coupled with shaft (290), and isconfigured to rotate unitarily therewith. Encoder wheel (292) has aplurality of slots (294) formed therethrough. Slots (294) fan radiallyoutward, and are angularly spaced apart relative one another. Of course,slots (294) may have any other suitable configuration. A sensor (296) ispositioned adjacent to encoder wheel (292). In particular, sensor (296)is positioned such that slots (294) successively pass before sensor(296) as encoder wheel (292) rotates with shaft (290). Sensor (296) maytherefore be used to count the passage of slots (294), which may betranslated into data indicative of the rotational position of manifold(144). In other words, since encoder wheel (292) and manifold (144)rotate concomitantly when biopsy probe (102) is coupled with holster(202) in the present example, the passage of slots (294) past sensor(296) during rotation of shaft (290) may be indicative of manifold (144)rotation, and therefore of manifold (144) position. It will beappreciated that information indicative of manifold position (144) maybe further indicative of which particular chamber (166) is aligned withcutter lumen (52). Suitable uses for such information will be apparentto those of ordinary skill in the art in view of the teachings herein.

Suitable devices that may be used for sensor (296) will also be apparentto those of ordinary skill in the art in view of the teachings herein.Similarly, suitable substitutes for encoder wheel (292) and sensor (296)will be apparent to those of ordinary skill in the art, including butnot limited to combinations of magnets and hall effect sensors, lightsources and photosensors, etc. Furthermore, other ways in which a tissueholder rotation mechanism (280) may be configured or operated will beapparent to those of ordinary skill in the art in view of the teachingsherein.

III. Exemplary Probe for Ultrasound Use

As shown in FIGS. 33-37, an alternative biopsy probe (103) comprises aneedle portion (350) and a body portion (352). Body portion (352)comprises a cover member (354) and a base member (356). A tissue sampleholder (368) is removably secured to base member (356), though tissuesample holder (368) may alternatively be secured to cover member (354)or some other component. As will be described in greater detail below, apair of tubes (402, 404) are coupled with probe (103). As will also bedescribed in greater detail below, and as noted above, biopsy probe(103) is configured to be coupled with a holster (302) to provide abiopsy device (101).

A. Exemplary Needle

In the present example, needle portion (350) comprises an outer cannula(12) having a tissue piercing tip (14) and a transverse tissue receivingaperture (16) located proximally from the tissue piercing tip (14). Inthis example, these components are essentially the same as thecomponents bearing the same names and item numbers described above, sothey will not be described in greater detail here. In other words, thefeatures, properties, and components of outer cannula (12), tip (14),and aperture (16) as described above (including cannula lumen (20),vacuum lumen (40), wall (30), transverse openings (32), etc.) may be thesame for needle portion (350) as they were described above with respectto needle portion (10). Of course, they may alternatively be varied inany suitable way, as desired.

Similarly, cutter (50) in probe (103) may have the same relationshipwith needle portion (350) as the relationship described above betweencutter (50) and needle portion (10); as well as all the same features,properties, and components as cutter (50) described above in the contextof probe (102). Such aspects of cutter (50) will also therefore not berepeated here.

B. Exemplary Needle Hub

As shown in FIGS. 36-37, a needle hub (358) is secured to outer cannula(12) of probe (103), and comprises a thumbwheel (62) and a sleeveportion (360) extending proximally from thumbwheel (62). Needle hub(358) of the present example is overmolded about a proximal portion ofouter cannula (12), though needle hub (358) may be formed and/or securedrelative to outer cannula (12) using any other suitable techniques(e.g., set screws, etc.). Furthermore, while needle hub (358) of thepresent example is formed of a plastic material, any other suitablematerial or combination of materials may be used.

Sleeve portion (360) of the present example comprises an annularprojection (66), a plurality of flats (362), and a transverse opening(70), which is formed near the proximal end of sleeve portion (360). Apair of o-rings (72) are positioned such that one o-ring (72) isproximal to transverse opening (70) and another o-ring (72) is distal totransverse opening (70). As will be described in greater detail below,transverse opening (70) is in fluid communication with the interiordefined by needle hub (60), as well as with vacuum lumen (40) of outercannula (12). In the present example, another transverse opening (70) isformed through sleeve portion (360), also between o-rings (72), andopposite to the other transverse opening (70). Other suitableconfigurations for sleeve portion (360) will be apparent to those ofordinary skill in the art in view of the teachings herein.

Thumbwheel (62) of sleeve portion (360) is essentially the same as, andmay be operated in a manner similar to, thumbwheel (62) of sleeveportion (64) of probe (102) described above. Thumbwheel (62) willtherefore not be discussed in any greater detail here. Of course,thumbwheel (62) may alternatively be varied in any suitable way, asdesired, if not omitted altogether, in the case of either probe (102,103).

In the present example, an exposed gear (364) is slid onto sleeveportion (360). In particular, the interior of gear (364) is configuredto mate with flats (362) of sleeve portion (360), such that gear (364)rotates unitarily with sleeve portion (360). With sleeve portion (360)being unitarily engaged with outer cannula (12), rotation of gear (364)will further cause rotation of cannula (12) for reorienting aperture(16). Gear (364) is exposed through base member (356), and is furtherconfigured to engage with a complimentary exposed gear (not shown) of aholster (not shown). In particular, gear (364) is configured to meshwith a complimentary exposed gear such that the complimentary gear canimpart rotation to gear (364), thereby rotating outer cannula (12).However, in the present example, gear (364) is not engaged with acomplimentary gear when probe (103) is coupled with holster (302). Itwill therefore be appreciated that, like other components and featuresdescribed herein, gear (364) and flats (362) may simply be omitted ifdesired.

C. Exemplary Needle Manifold

As shown in FIGS. 34-36, a needle manifold (366) is provided aboutsleeve portion (360). Needle manifold (366) is fixed relative to basemember (356) in this example. Needle manifold (366) is in fluidcommunication with tube (402), such that tube (402) may communicatesaline, a vacuum, and/or pressurized air, etc., to needle manifold (366)as will be described in greater detail below. Needle manifold (366) isfurther in fluid communication with the interior of sleeve portion(360), via transverse openings (70), one of which is shown in FIG. 37.O-rings (64) are configured to maintain a fluid seal between needlemanifold (366) and sleeve portion (360), even as sleeve portion (360)rotates relative to needle manifold (366). A seal (not shown) is mayalso provided at the proximal end of sleeve portion (360), at theinterface between sleeve portion (360) and cutter (50). Needle manifold(366), sleeve portion (360), and outer cannula (12) are thus configuredand arranged such that saline, a vacuum, and/or pressurized air, etc.that is communicated via tube (402) to needle manifold (366) will becommunicated to vacuum lumen (40) via transverse openings (70). Ofcourse, any other suitable structures or arrangements may be used tocommunicate saline, a vacuum, and/or pressurized air, etc. from tube(402) to vacuum lumen (40).

D. Exemplary Cutter Rotation and Translation Mechanism

In the present example, and as shown in FIGS. 34-35, body portion (350)of probe (103) comprises a cutter rotation and translation mechanism(120), which is operable to rotate and translate cutter (50) withinouter cannula (12). Cutter rotation and translation mechanism (120) inthis example has essentially the same components, features, andoperability of the cutter rotation and translation mechanism (120)described above with respect to probe (102). Cutter rotation andtranslation mechanism (120) will therefore not be discussed in anygreater detail here. Of course, cutter rotation and translationmechanism (120) may alternatively be varied in any suitable way, asdesired, in the case of either probe (102, 103).

E. Exemplary “Sharps Reduction” Variation

In addition, needle portion (350) and cutter (50) of biopsy probe (103)may be configured to be removable from biopsy probe (103) in essentiallythe same manner as described above with respect to removability ofneedle portion (10) from biopsy probe (102). For instance, body portion(352) may include a feature similar to release tab (118), or any othersuitable feature, to provide, permit, or facilitate removability ofneedle portion (350) and cutter (50) from body portion (352).

F. Exemplary Tissue Sample Holder Manifold

As shown in FIGS. 38-40, a tissue sample holder (368) is provided at theend of body portion (352) of probe (103). Tissue sample holder (368)comprises a cup (142), a manifold (370), and a plurality of trays (372).Manifold (370) includes a central recess (146), a plurality of openings(374), and a longitudinally extending sidewall (382). Sidewall (382)only extends for a portion of the length of manifold (370) in thisexample, though sidewall (382) may alternatively extend to any otherdegree as desired. Manifold (370) also includes a plurality of radiallyextending walls (380). Walls (380) and the interior surface of sidewall(382) define a plurality of longitudinal passages (376). Eachlongitudinal passage (376) is in fluid communication with acorresponding opening (374).

In addition, walls (380) and the exterior surface of sidewall (382)define a plurality of chambers (378). With sidewall (382) providingclearance (e.g., by not extending the full length of manifold (370)),each chamber (378) is in fluid communication with a correspondinglongitudinal passage (376). Manifold (370) is thus configured such thateach opening (374) is in fluid communication with a correspondingchamber (378). Of course, any other suitable structures orconfigurations for manifold (370) may be used. For instance, manifold(144) described above with respect to biopsy probe (102) may be usedwith biopsy probe (103) in lieu of manifold (370) being used with biopsyprobe (103). Likewise, manifold (370) may be used with biopsy probe(102) in lieu of manifold (144) being used with biopsy probe (102).

G. Exemplary Tissue Sample Trays

Trays (372) of the present example are configured to be placed onmanifold (370), and to receive tissue samples (4) as will be describedin greater detail below. Each tray (372) has a plurality of baseportions (382), a plurality of hollow wall portions (384), and aplurality of webs (386). Base portions (392), hollow wall portions(384), and webs (386) define chambers (388). By way of example only,each chamber (388) may be configured to receive a single tissue sample(4) captured by cutter (50). Alternatively, chambers (388) may beconfigured such that each chamber (388) may hold more than one tissuesample (4). As shown, the underside of each hollow wall portion (384) isconfigured to receive a wall (380) of manifold (370). As is also shown,each hollow wall portion (384) has a generally tapered configuration,though any other suitable configuration may be used.

In addition, trays (372) have a plurality of openings (390), extendinglongitudinally, formed through the base portion (392) within eachchamber (388). Openings (390) continue, extending radially outwardly,through a portion of each web (386). Accordingly, with sidewall (382)not extending the full length of manifold (370), the openings (390)permit fluid communication between each longitudinal passage (376) andeach corresponding chamber (388). In other words, each opening (374) isin fluid communication with a corresponding chamber (388).

Each tray (372) may further comprise one or more types of markings orother indicia to distinguish one chamber (388) from another chamber(388). Such markings or indicia may be similar to the same describedabove with respect to chambers (166) of trays (160). Accordingly,discussion of such markings or indicia will not be repeated here.Similarly, cup (142) of tissue sample holder (368) is essentially thesame as cup (142) of tissue sample holder (140) described above.Discussion of cup (142) will therefore not be repeated here.

H. Exemplary Rotation and Alignment of Manifold

Manifold (370) of the present example is configured to rotate relativeto base member (356), as will be described in greater detail below.Manifold (370) of the present example is further configured such thateach opening (374) may be selectively aligned with a port (not shown)that is in fluid communication with tube (404). Such alignment of anopening (374) and such a port will place the aligned opening (374) influid communication with tube (404), such that induction of a vacuumwithin tube (404) will effect induction of a vacuum through opening(374), as well as within the chamber (388) associated with that opening(374). In addition, manifold (370) and trays (372) of the presentexample are configured such that each chamber (388) may be selectivelyplaced in fluid communication with cutter lumen (52). It will thereforebe appreciated that a vacuum in tube (406) may induce a vacuum in cutterlumen (52), with the vacuum being communicated via the above-noted port,an associated opening (374), an associated longitudinal passage (376),and an associated chamber (388). Of course, there are a variety of otherways in which a vacuum may be induced within a cutter lumen (52), andany other suitable structures or techniques may be used. Furthermore,pressurized air, a liquid (e.g., saline), or any other fluid may becommunicated through the above-mentioned components in lieu of or inaddition to a vacuum being induced therein.

A gear (170) is engaged with manifold (370) of the present example. Inparticular, gear (170) is inserted within central recess (146) ofmanifold (370). Gear (170) and central recess (146) of manifold (370)are essentially the same in configuration and in operation as gear (170)and central recess (146) described above with respect to manifold (144).For instance, gear (170) is configured to mesh with a complimentary gear(210) of holster (302), such that gear (210) may be used to impartrotation to gear (170). Such rotation may be used to selectively (e.g.,consecutively) align chambers (388) with cutter lumen (52), tosuccessively collect a discrete tissue sample (4) in each chamber (388)during use of biopsy device (101). Furthermore, such collection oftissue samples (4) may be performed without having to withdraw andre-insert needle portion (350) relative to patient during such aprocess.

I. Exemplary “Parking Pawl”

Body portion (352) of the present example further comprises a pawlportion (182) having teeth (not shown). Pawl portion (182) isresiliently urged for the teeth to engage with gear (170). Pawl portion(182) in this context is thus essentially the same in configuration andoperability as pawl portion (182) discussed above in the context ofengagement member (180) of probe (102). Accordingly, the similar detailson configuration, function, operability, etc. will not be repeated here.However, it should be noted that in the present example, pawl portion(182) is integral with the remainder of base member (356), rather thanbeing provided as part of a separate engagement member (180). Of course,body portion (352) may be modified such that pawl portion (182) isprovided as part of a separate piece that is secured relative to basemember (356). Similarly, base member (116) of probe (102) may bemodified such that pawl portion (182) is formed as an integral piece ofbase member (116), in lieu of being part of a separate engagement member(180) that is secured relative to base member (116). Still othervariations will be apparent to those of ordinary skill in the art inview of the teachings herein. In addition, it will be appreciated that abiopsy device (101) may lack a pawl portion (182) altogether, such thata manifold (370) may freely rotate when biopsy probe (103) is notcoupled with a holster (302).

J. Exemplary Dedicated Chamber

As shown in FIGS. 38-40, tissue sample holder (368) of the presentexample has a passage (158) formed through manifold (370). Passage (158)of manifold (370) is essentially the same in configuration, function,operability, etc. as passage (158) of manifold (144) described above.Details of passage (158) will therefore not be repeated here. However,it will be noted that, like passage (158) of manifold (144), passage(158) of manifold (370) may be used to pass instruments such as biopsysite marker deployment devices, an applier (90), and/or other devices orliquids, etc., into and/or through cutter lumen (52). Similarly, biopsyprobe (103) may be initially provided with passage (158) being alignedwith cutter lumen (52) by default.

Cup (142) of tissue sample holder (368) further comprises an opening(176) and a hatch (178). Cup (142), opening (176), and hatch (178) oftissue sample holder (368) are essentially the same in configuration,function, operability, etc. as cup (142), opening (176), and hatch (178)of tissue sample holder (140). Accordingly, details of cup (142),opening (176), and hatch (178) will not be repeated here.

IV. Exemplary Holster for Ultrasound Use

As shown in FIGS. 41-45, an alternative holster (302) comprises a tophousing member (304), through which a portion of each of gears (208,210) is exposed, and a bottom housing member (306). Boss (212) isprovided on top housing member (304), and is configured to disengagepawl portion (182) from gear (170) when biopsy probe (103) is coupledwith holster (302). A plurality of hook members (305) extend from tophousing member (304) for selectively securing probe (103) to holster(302), though other structures or techniques may be used. Holster (302)of this example further comprises a cutter drive mechanism (310) and atissue holder rotation mechanism (320). Each of these merely exemplarycomponents will be described in greater detail below. Holster (302) ofthe present example is configured to be coupled with a biopsy probe(103), such as biopsy probe (103) described above, to provide a biopsydevice (101). In addition, holster (302) is configured to be handheld,such that biopsy device (101) may be manipulated and operated by asingle hand of a user (e.g., using ultrasound guidance, etc.). However,it will be appreciated in view of the disclosure herein that holster(302) may be used in a variety of other settings and combinations. Byway of example only, holster (302) may alternatively be coupled withbiopsy probe (102) instead of biopsy probe (103). As another merelyillustrative example, holster (302) may be coupled with a variation ofbiopsy probe (102) that has a modified needle hub (60) (e.g., a needlehub (60) that is shorter, not configured for firing needle portion (10),etc.)

A. Exemplary Cutter Drive Mechanism

As shown in FIG. 44, cutter drive mechanism (310) of the present examplecomprises a motor (312) with a shaft (314) extending therefrom. Gear(208) is mounted to shaft (314), and is configured to rotate unitarilytherewith. As noted above, a portion of gear (208) is exposed throughtop housing member (304), such that gear (208) meshes with gear (138) ofcutter rotation and translation mechanism (120) when biopsy probe (103)is coupled with holster (302). Accordingly, when motor (312) isactivated to rotate, such rotation may be communicated via shaft (314)and gears (208, 138), to effect simultaneous rotation and translation ofcutter (50) as described above. Other ways in which a cutter drivemechanism (310) may be configured or operated will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

B. Exemplary Tissue Holder Rotation Mechanism

As shown in FIG. 45, tissue holder rotation mechanism (320) of thepresent example comprises a motor (322) having a shaft (324) with a gear(326) mounted thereto, such that gear (326) rotates unitarily with shaft(324). Gear (326) is configured to mesh with gear (328), which ismounted to shaft (330). Gear (210), which has been noted above, is alsomounted to shaft (330), at the proximal end of shaft (330). Inparticular, gear (210) is configured to mesh with gear (170) of tissuesample holder (368) when biopsy probe (103) is coupled with holster(302). Accordingly, when motor (322) is activated to rotate, suchrotation may be communicated via shafts (324, 330) and gears (326, 328,210, 170), to effect rotation of manifold (370) as described above.

In addition, an encoder wheel (292) is coupled with shaft (330), and isconfigured to rotate unitarily therewith. Encoder wheel (292) has aplurality of slots (294) formed therethrough, similar to slots (294)noted above. A sensor (296) is positioned adjacent to encoder wheel(292). In particular, sensor (296) is positioned such that slots (294)successively pass before sensor (296) as encoder wheel (292) rotateswith shaft (290). Sensor (296) may therefore be used to count thepassage of slots (294), which may be translated into rotational positionof manifold (366). In other words, since encoder wheel (292) andmanifold (366) rotate concomitantly when biopsy probe (103) is coupledwith holster (302) in the present example, the passage of slots (294)past sensor (296) during rotation of shaft (330) may be indicative ofmanifold (366) rotation, and therefore of manifold (366) position. Itwill be appreciated that such information may be further indicative ofwhich particular chamber (388) is aligned with cutter lumen (52).Suitable uses for such information will be apparent to those of ordinaryskill in the art in view of the teachings herein. Suitable devices thatmay be used for sensor (296) will also be apparent to those of ordinaryskill in the art in view of the teachings herein. Furthermore, otherways in which a tissue holder rotation mechanism (320) may be configuredor operated will be apparent to those of ordinary skill in the art inview of the teachings herein.

C. Exemplary Illumination Features

As shown in FIGS. 41-43, holster (302) of the present example furtherincludes a plurality of LEDs (308, 316, 318). In particular, a pair ofLEDs (308) are provided on the distal end of holster (302). The lightemitted by LEDs (308) is viewable through openings formed in the distalend of top housing member (304). LEDs (308) are positioned andconfigured to act as “headlights” for biopsy device (101), such as byilluminating a site of a patient where needle portion (350) is to beinserted. LEDs (308) may be continuously activated, such as beingactivated while biopsy device (101) is activated. Alternatively, LEDs(308) may be selectively activated, such as by a switch (not shown) onholster (302), on probe (103), on vacuum control module (400), orotherwise. Other ways in which LEDs (308) may be activated, positioned,or otherwise operated or configured will be apparent to those ofordinary skill in the art in view of the teachings herein.

LEDs (316, 318) are provided on the proximal end of holster (302). Thelight emitted by LEDs (316, 318) is viewable through openings formed inthe distal end of bottom housing member (306). As shown, LEDs (316) areeach positioned on either side of LED (318), which is positioned betweengear (210) and boss (212). LEDs (316) are configured to provideillumination of tissue sample holder (368). In particular, manifold(370) and other components are configured to permit illumination oftissue sample holder (368) by LEDs (316, 318) in this example. Forinstance, manifold (370), gear (170), shaft (172), and/or othercomponents may be formed of a substantially transparent or substantiallytranslucent material, including combinations of materials providing acombination of transparent and/or translucent properties. Cup (142) mayalso be substantially transparent or substantially translucent to permita user to see at least some amount of light emitted by LEDs (316, 318).Suitable selections and arrangements of materials and components forpermitting illumination of tissue sample holder (368) by LEDs (316, 318)will be apparent to those of ordinary skill in the art in view of theteachings herein.

It will also be appreciated that one or more of LEDs (316, 318) may bepositioned to illuminate a particular chamber (388) within tissue sampleholder (368), rather than illuminating the entire tissue sample holder(368). For instance, LEDs (316, 318) may be configured to illuminate anactive chamber (388), such as the chamber (388) located in the nineo'clock, twelve o'clock, and/or three o'clock position. Furthermore, oneor more of LEDs (308, 316, 318) may be configured to flash or changecolor to indicate an error condition (e.g., blocked cutter lumen (52),probe (103) insufficiently coupled with holster (302), leakage in a tube(402, 404, 408, 410), etc.). Other ways in which LEDs (316, 318) may beactivated, positioned, or otherwise operated or configured will beapparent to those of ordinary skill in the art in view of the teachingsherein.

It will also be appreciated that holster (202) may be modified toinclude any of LEDs (308, 316, 318). Similarly, manifold (144) and/orother components of probe (102) may be configured to permit manifold(144) to be illuminated by LEDs (316, 318); and cup (142) may beconfigured to permit a viewer to observe illumination of manifold (144)in biopsy device (100). Alternatively, any or all of LEDs (308, 316,318) may simply be omitted from biopsy device (100, 101) altogether.

While LEDs (308, 316, 318) have been described in the present example asproviding illumination, any other suitable source of light may be used,including but not limited to an incandescent bulb. Alternatively, abiopsy device (100, 101) may lack a source of light altogether.

V. Exemplary Vacuum Control Module and Canister

FIGS. 46-47 show an exemplary vacuum control module (400) and anexemplary vacuum canister (500). As shown, vacuum canister (500) isconfigured to be inserted into vacuum control module (400). As will bedescribed in greater detail below, vacuum control module (400) isoperable to induce a vacuum through vacuum canister (500), and such avacuum may be communicated to biopsy probe (102, 103) as describedabove. Furthermore, vacuum canister (500) is operable to collect fluidsthat are communicated from biopsy probe (102, 103) during use of biopsyprobe (102, 103). Vacuum canister (500) may thus be regarded asproviding a fluid interface between biopsy probe (102, 103) and vacuumcontrol module (400).

A. Exemplary Vacuum Canister

As shown in FIGS. 48-51, vacuum canister (500) comprises a base portion(502), a lid portion (506), and a handle (508). Handle (508) isconfigured to be gripped by a user when user inserts vacuum canister(500) into vacuum control module (400) or withdraws vacuum canister(500) from vacuum control module (400), as will be described in greaterdetail below. Base portion (502) is substantially hollow, and isconfigured to provide a reservoir (504) for collection of fluids (e.g.,saline, blood, etc.) communicated from biopsy probe (102, 103).

Lid portion (506) of the present example has tracks (530) formed in itssides. Tracks (530) are configured to engage with rails (460) in thecanister compartment (458) of vacuum control module (400), as will bedescribed in greater detail below. Tracks (530) each have a flaredportion (532) to provide guidance for tracks (530) to engage rails(460), to thereby facilitate insertion of vacuum canister (500) intocanister compartment (458) of vacuum control module (400). In otherembodiments, tracks (530) are provided on base portion (502).Alternatively, tracks (530) may be substituted or supplemented with anyother suitable structures in any other suitable location(s), or may besimply omitted altogether.

In the present example, lid portion (506) has a plurality of trenches(510) formed therein. As will be described below, trenches (510) areconfigured to receive tubes (402, 404, 408, 410). A plurality of topports (512) are formed on lid portion (506), and each top port (512) isconfigured have one of tubes (402, 404) coupled therewith. Inparticular, each top port (512) is configured to provide a path forfluid communication from a connected tube (402, 404) to the reservoir(504) defined by base portion (502). Lid portion (506) further comprisesa vacuum port (514), which is configured to be placed in fluidcommunication with a vacuum source (412) in vacuum control module (400),as will be described in greater detail below. Vacuum port (514) includesa pair of o-rings (534) configured to provide a seal when engaged with acomplimentary vacuum port (462) as will be described in greater detailbelow. It will be appreciated in view of the teachings herein that, whenvacuum source (412) is used to generate a vacuum, such a vacuum may becommunicated to tubes (402, 404) via vacuum port (514), reservoir (504),and top ports (512). The vacuum may be further communicated to biopsyprobe (102, 103) via tubes (402, 404). Lid portion (506) also includes avent recess (544), configured for venting the open end of a vent tube(410) into. Such venting will be described in greater detail below.

Lid portion (506) also has a cap (526) that is removably secured to anaccess port (528). Cap (526) is configured to provide a seal of accessport (528) during use of biopsy system (2). After biopsy system (2) hasbeen used, and liquid is present in reservoir (504), cap (526) may beremoved to gain access to reservoir (504). Of course, like othercomponents mentioned herein, cap (526) and access port (528) are merelyoptional, and may be varied, substituted, supplemented, or simplyomitted altogether as desired.

As best seen in FIG. 51, a float (516) is provided in a cage (518),which extends from the bottom of lid portion (506) into reservoir (504).While float (516) is shown as having a spherical shape, any othersuitable shape may be used. An elastomeric funnel member (520) ispartially disposed in and engaged with cage (518). In addition, ahydrophobic filter (522) is provided between the bottom of lid portion(506) and funnel member (520). A conduit (524) is formed in lid portion(506), providing fluid communication from vacuum port (514) to filter(522) and funnel member (520), and therefore, to reservoir (504). Filter(522) is configured to prevent communication of liquids (e.g., saline,blood, etc.) from reservoir (504) through conduit (524) and vacuum port(514); while permitting a vacuum to be communicated or inducedtherethrough.

Float (516) has properties (e.g., density) such that it will float in aliquid but will not be drawn upward when a vacuum is induced withinreservoir (504). In other words, when vacuum source (412) is activatedto induce a vacuum through vacuum port (514), float (516) will notnecessarily be drawn up against funnel member (520). The vacuum maytherefore be communicated “around” float (516) and through funnel member(520). However, as reservoir (504) fills with liquid, float (516) willbegin to float up toward funnel member (520). Eventually, liquid drawninto reservoir (504) via tubes (402, 404) and top ports (512) may reacha level within reservoir (504) to a point where float (516) engagesfunnel member (520) in a manner sufficient to prevent fluid from passingbetween float (516) and funnel member (520). Furthermore, suchengagement between float (516) and funnel member (520) may prevent avacuum from being communicated to reservoir (504) by vacuum port (514).Such blockage of vacuum communication may be sensed within biopsy system(2), and may trigger some sort of notification that vacuum canister(500) is substantially full of liquid. For instance, a vacuum blockagemay affect an automatic shutoff of vacuum source (412). A vacuumblockage may also trigger a visual indication on a graphical userinterface and/or an audible signal.

Those of ordinary skill in the art will appreciate in view of theteachings herein that filter (522), float (516), cage (518), and funnelmember (520) are all merely exemplary. Indeed, any other suitabledevices or structures may be used in addition to or in lieu of suchcomponents. Alternatively, such components may be simply omittedaltogether. In other words, the inventors contemplate that a variety ofother configurations for vacuum canister (500) may be used, and that,like every other component of biopsy system (2) described herein, vacuumcanister (500) need not be limited to the particular construction thatis explicitly described herein.

B. Exemplary Tube Connection and Configuration

FIG. 50 shows an example of tubes (402, 404, 408, 410) being provided intrenches (510). Trenches (510) may include one or more featuresconfigured to retain tubes (402, 404, 408, 410) within trenches (510).For instance, inwardly-directed ribs or protrusions may be provided nearthe tops of trenches (510). Alternatively, the sidewalls of trenches(510) may provide an interference fit; or may be slanted, such that thetops of the sidewalls of trenches (510) provide less clearance than thebottoms of the sidewalls. Alternatively, an adhesive may be used tosecure tubes (402, 404, 408, 410) within trenches (510). As yet anothervariation, one or more caps, clasps, or other members may be securedover portions of tubes (402, 404, 408, 410) to secure tubes (402, 404,408, 410) within trenches (510). Other ways in which tubes (402, 404,408, 410) may be secured or retained within trenches (510) will beapparent to those of ordinary skill in the art.

A plurality of top ports (512) are formed on lid portion (506), and eachtop port (512) is configured have one of tubes (402, 404) coupledtherewith. In particular, each top port (512) is configured to provide apath for fluid communication from a connected tube (402, 404) to thereservoir (504) defined by base portion (502). In one embodiment,canister (500) is pre-packaged with tubes (402, 404, 408, 410) alreadypositioned in trenches (510), in addition to having tubes (402, 404)coupled with probe (102, 103) prior to product packaging. In otherembodiments, canister (500) and/or probe (102, 103) may be packagedwithout some or all of tubes (402, 404, 408, 410) already connected.However, in some embodiments where canister (500) and probe (102, 103)come with tubes (402, 404, 408, 410) pre-connected, aside from insertingcanister (500) in canister compartment (458) as described below, a usermay have connection of tube (408) with a saline bag (444) as the onlyfluid connection that the user needs to make. Of course, in embodimentswhere saline is not used, fluid communication for biopsy system (2) maybe ready for use as soon as the user inserts canister (500) intocanister compartment (458).

As is shown in FIG. 1, tube (408) is fed into tube (402). As is shown inFIGS. 1 and 50, tube (410) is also fed into tube (402). In particular, aconnector (446) connects vent tube (410) with tube (402); and aconnector (448) connects saline tube (408) with tube (402). As shown,connector (446) is provided adjacent to canister (500), while connector(448) is provided near biopsy probe (102, 103). In the present example,connectors (446, 448) simply provide a constantly open conduit betweentubes (410, 402) and tubes (408, 402), respectively. In otherembodiments, connectors (446, 448) may have any other suitablecomponents (e.g., valve, etc.). It will be appreciated in view of thedisclosure herein that the configuration of tubes (402, 408, 410) andconnectors (446, 448) permits any of a vacuum, vent, or saline to becommunicated through tube (402). An exemplary determination of which ofthese will be communicated through tube (402) will be described ingreater detail below.

C. Exemplary Vacuum Control Module

As shown in FIGS. 46-47 and 52-58, the vacuum control module (400) ofthe present example comprises an outer casing (414), a vacuum canisterslot (416), a handle portion (418), and a user interface (700). Outercasing (414) includes a face portion (420), behind which resides adisplay screen (702), capacitive switches (704), and a speaker (706).Face portion (420) is configured such that display screen (702) can beviewed therethrough; such that capacitive switches (704) may beactivated therethrough; and such that sounds coming from speaker (706)can be heard therethrough. As will be described in greater detail below,display screen (702), switches (704), and speaker (706) may be regardedas collectively forming user interface (700). Outer casing (414) furthercomprises a top cover (422), a wraparound cover (424), and trim pieces(426).

Outer casing (414) is configured such that outer casing (414) isrelatively easy to clean. For instance, surface transitions (e.g.,between face portion (420), top cover (422), a wraparound cover (424),and trim pieces (426), etc.) are reduced. Furthermore, with capacitiveswitches (704) being provided behind face portion (420) in lieu ofconventional push buttons or other mechanical input components, fluidingress and dirt capture areas are reduced if not eliminated.

As shown in FIG. 53, vacuum control module (400) of the present examplefurther comprises a base portion (428), which has a pair of uprightmembers (430) extending upwardly therefrom and inwardly toward eachother, meeting at handle portion (418). Accordingly, base portion (428),upright members (430), and handle portion (418) are configured such thatwhen a user carries vacuum control module (400) by handle portion (418),the weight of vacuum control module (400) is borne by base portion (428)and upright members (430). In one embodiment, upright members (430) andhandle portion are collectively formed by a unitary metal member fixedlysecured to base member (428), such as via screws, bolts, welds, or usingother components or techniques. Handle portion (418) may furthercomprise a plastic overmold formed about such a unitary metal member. Ofcourse, as with other components described herein, upright members (430)and handle portion (418) may be formed in a variety of alternative waysusing a variety of alternative structures and techniques.

With handle portion (418), vacuum control module (400) may be providedas a substantially portable unit. For instance, vacuum control module(400) may have a size and weight (e.g., less than 10 kg) such that asingle user may pick up and carry control module (400), by handleportion (418) or otherwise, with relative ease. Vacuum control module(400) may also be used with or without a cart. For instance, portabilityof vacuum control module (400) may permit it to simply be set on atabletop or other location. Such portability may be desirable in MRIsuite settings or in other settings.

Vacuum control module (400) of the present example also includes fans(432) and a vent (433), though these components may be varied oromitted. Vacuum control module (400) also includes a ground lug (434), aUSB port (436), and an Ethernet port (438). In addition, vacuum controlmodule (400) includes a cord socket (435) for connecting vacuum controlmodule (400) to an AC outlet using a conventional cord, and a powerswitch (439). It will be appreciated by those of ordinary skill in theart in view of the teachings herein that USB port (436) and/or Ethernetport (438) may be used to couple vacuum control module (400) with avariety of other devices, including but not limited to a local or remotedesktop or laptop computer, the internet, a local area network, anyother network, a storage device, or a device associated with one or moreparticular imaging modalities (e.g., a pod or cart associated withMagnetic Resonance Imaging, etc.). Such ports (436, 438) may permit dataand/or commands to be communicated from vacuum control module (400) toan external device. In addition or in the alternative, ports (436, 438)may permit data and/or commands to be communicated from an externaldevice to vacuum control module (400). Other ways in which ports (436,438) may be used will be apparent to those of ordinary skill in the artin view of the teachings herein. Similarly, it will be appreciated thatports (436, 438) may be substituted, supplemented, varied, or omitted asdesired.

As also shown in FIG. 53, a vacuum pump (440) is provided in vacuumcontrol module (400). A muffler assembly (442) connected to vacuum pump(440) to reduce noise generated by vacuum pump (440). Vacuum pump (440)and muffler assembly (442) thus collectively provide a vacuum source(412) in the present example, though any other suitable components maybe used. For instance, muffler assembly (442) is merely optional. Vacuumpump (440) and muffler assembly (442) are fixedly secured relative tobase portion (428), such as via screws, bolts, welds, or using othercomponents or techniques. One or more rubber feet (not shown) or similarcomponents may be positioned between vacuum pump (440) and base portion(428) to absorb vibration generated by vacuum pump, such as to furtherreduce noise. Other ways in which noise from vacuum pump (440) may bereduced will be apparent to those of ordinary skill in the art in viewof the teachings herein.

In the present example, saline is provided for biopsy system (2) by aconventional saline bag (444), which is separate from vacuum controlmodule (400). For instance, saline bag (444) may be coupled with tube(408) using any suitable conventional fitting. In other embodiments,saline is provided from within vacuum control module (400). Forinstance, vacuum control module (400) may include a feature (not shown)that is operable to receive a conventional saline bag (444), with a port(not shown) for placing tube (408) in fluid communication with salinebag (444). Vacuum control module (400) may alternatively include someother type of reservoir within casing (414) for providing saline. Inother embodiments, saline is not used at all with biopsy system (2). Itwill also be appreciated that vacuum control module (400) may alsoinclude a source of pressurized air, such as a pump or charged canister,etc. Such pressurized air may be communicated to a biopsy device (100,101) for any suitable purpose, including but not limited tocommunicating pressurized air through one or more lumens (20, 40, 52),activating a component (e.g., pneumatic motor or actuator, etc.) withinbiopsy device (100, 101), or for any other purpose. Still othercomponents that may be incorporated into or otherwise associated withvacuum control module (400) will be apparent to those of ordinary skillin the art in view of the teachings herein.

D. Exemplary Vacuum Canister Port in Control Module

As shown in FIGS. 53-58, vacuum control module (400) of the presentexample further comprises a vacuum canister port assembly (450). Vacuumcanister port assembly (450) comprises a bracket (452), an inner casing(454), and a plurality of solenoids (456). Bracket (452) is configuredto be fixedly secured relative to base portion (428), such as viascrews, bolts, welds, or using other components or techniques. Heatsinks (459) are secured to bracket (452), as are solenoids (456) andinner casing (454).

Inner casing (454) defines a canister compartment (458), which isconfigured to receive vacuum canister (500) as noted above. Inparticular, rails (460) extend inwardly from the interior of bracket(452), through the sidewalls of inner casing (454), and into canistercompartment (458). As described above, rails (460) are configured toengage tracks (530) on vacuum canister (500), to guide vacuum canister(500) as vacuum canister (500) is inserted into canister compartment(458). Each rail (460) has a tapered portion (460) to facilitateengagement with tracks (530) in the present example, though taperedportions (460) are merely optional. It will be appreciated in view ofthe disclosure herein that rails (460) may alternatively extend inwardlyonly from the sidewalls of inner casing (454) rather than from bracket(452). Alternatively, rails (460) may be otherwise configured orpositioned, or may be omitted altogether.

E. Exemplary Vacuum Canister Quick-Connect

Inner casing (454) of the present example also includes a vacuum port(462). A port coupler (464) is provided on the exterior of inner casing(454), opposite to vacuum port (462), and is in fluid communication withvacuum port (462). Port coupler (464) is configured to be connected witha tube, hose, or other structure for fluidly coupling port coupler (464)with vacuum pump (440). In other words, vacuum pump (440) may be placedin fluid communication with vacuum port (462) via a tube (not shown)connected with port coupler (464), such that vacuum pump (440) may drawa vacuum through vacuum port (462). Vacuum port (462) is configured toengage with vacuum port (514) of vacuum canister (500) when vacuumcanister (500) is inserted into canister compartment (458). Inparticular, vacuum port (462) provides a female-shaped compliment tomale-shaped vacuum port (514). O-rings (534) on vacuum port (514) areconfigured to provide sealed engagement between vacuum port (462) andvacuum port (514). Of course, the male-female arrangement between vacuumports (462, 514) may be reversed, or some other relationship betweenvacuum ports (462, 514) may be provided. Furthermore, other variationsmay be used where o-rings (534) are substituted, supplemented, oromitted altogether.

F. Exemplary Pinching Valve System

Solenoids (456) each include a respective rod (470). Each rod (470) hasa corresponding engagement tip (472, 474, 476, 478) secured unitarilythereto. Each solenoid (456) is operable to selectively move its rod(470) with tip (472, 474, 476, 478) upward or downward when solenoid(456) is activated, the upward or downward movement being dependent onthe signal communicated to each solenoid (456). Rods (470) arepositioned such that, when vacuum canister (500) is inserted in canistercompartment (458), tips (472, 474, 476, 478) may be selectively engagedwith tubes (402, 404, 408, 410) through selective activation ofsolenoids (456). In particular, when vacuum canister (500) is insertedinto canister compartment (458) of vacuum control module (400), tip(472) is positioned to selectively engage saline tube (408), tip (474)is positioned to selectively engage vent tube (410), tip (476) ispositioned to selectively engage axial vacuum tube (404), and tip (478)is positioned to selectively engage lateral vacuum tube (402).

Recesses (536, 538, 540, 542) are formed in lid portion (506) of vacuumcanister (500), and are configured to provide sufficient clearance fortips (472, 474, 476, 478) to fully engage tubes (402, 404, 408, 410).Such engagement may include tips (472, 474, 476, 478) pinching tubes(402, 404, 408, 410) against lid portion (506) (e.g., using lid portion(506) as an engagement surface), to thereby prevent fluid communicationthrough tubes (402, 404, 408, 410).

In the present example, recess (536) is configured to permit tip (472)to fully engage saline tube (408), recess (538) is configured to permittip (474) to fully engage vent tube (410), recess (540) is configured topermit tip (476) to fully engage axial vacuum tube (404), and recess(542) is configured to permit tip (478) to fully engage lateral vacuumtube (402). Such full engagement of tips (472, 474, 476, 478) with tubes(402, 404, 408, 410) will serve to prevent fluid from being communicatedthrough fully engaged tubes (402, 404, 408, 410) in this example. Inother words, solenoids (456), rods (470), and tips (472, 474, 476, 478)may be used to serve a valving function with respect to tubes (402, 404,408, 410), such that selective activation of solenoids (456) may permitor prevent communication of fluid through tubes (402, 404, 408, 410).Suitable combinations of permitting/preventing fluid communicationthrough tubes (402, 404, 408, 410) during use of biopsy system (2) willbe described in greater detail below.

In some variations, each solenoid (456) is engaged with one or moreresilient members (e.g., springs, etc.). For instance, such resilientmembers may be located at the bottom of solenoids (456), and may be usedto control tolerance stack-up and match the force profile of solenoids(456) to the force profile of tubes (402, 404, 408, 410). Of course,such resilient members may be located elsewhere and may perform otherfunctions in addition to or in lieu of those mentioned above. Similarly,other components may be used to control tolerance stack-up and matchforce profiles. Alternatively, such resilient members or othercomponents may be simply omitted altogether.

While fluid control is provided by solenoids (456), rods (470), and tips(472, 474, 476, 478) in the present example, it will be appreciated thatfluid control may be provided in a variety of alternative ways. Forinstance, alternative valving devices or systems may be provided withinvacuum control module (400). Alternatively, all or some valvingfunctions may be performed within biopsy device (100, 102). Forinstance, a constant vacuum may be communicated to biopsy device (101,102), and a valving member within biopsy device (101, 102) may beoperable to selectively communicate such a vacuum to vacuum lumen (40)and/or cutter lumen (52). In other embodiments, one or more of motorswithin biopsy device (100, 101) may be used to control a vacuum pumpthat is located within biopsy device (100, 101) to provide a vacuum.Such a vacuum motor may be dedicated to controlling such a pump, or apreexisting motor (246, 272, 282, 312, 322) may be used to control sucha pump. Still other ways in which communication of fluid (e.g., saline,vacuum, venting, etc.), through tubes (402, 404, 408, 410) or otherwisewithin biopsy system (2), may be selectively controlled or provided willbe apparent to those of ordinary skill in the art in view of theteachings herein.

G. Exemplary Crushable Tubing

In some embodiments, and as shown in FIG. 59, tubes (402, 404, 408, 410)are formed with a plurality of longitudinal slits (490). In the presentexample, slits (490) extend along the full length of each of tubes (402,404, 408, 410). In other embodiments, slits (490) are provided onlyalong the portions of the lengths of tubes (402, 404, 408, 410) wheretubes (402, 404, 408, 410) will be selectively engaged by tips (472,474, 476, 478). With tubes (402, 404, 408, 410) being formed of a lowdurometer polymer with slits (490), tubes (402, 404, 408, 410) have arelatively low resistance to being crushed by tips (472, 474, 476, 478)in a manner sufficient for fluid communication to be stopped in a tube(402, 404, 408, 410) that is being crushed by a tip (472, 474, 476,478). However, tubes (402, 404, 408, 410) still have sufficient strengthto refrain from collapsing when a vacuum is induced within tubes (402,404, 408, 410), despite having slits (490). Tubes (402, 404, 408, 410)may also have sufficient thickness to provide resistance to kinking.

It will be appreciated in view of the teachings herein that slits (490)may be formed in tubes (402, 404, 408, 410) using a variety oftechniques. For instance, when tubes (402, 404, 408, 410) are formedusing a thermoplastics extrusion process, cold knives may be provided atthe exit of an extrusion die to cut the material while it is still hot.Alternatively, when tubes (402, 404, 408, 410) are formed using athermoset extrusion process, hot knives may be provided at the exit ofan extrusion guide to cut the material while it is still green.Alternatively, slits (490) may be formed by cutting downstream of acuring oven or cooling bath. Other ways in which slits (490) may beformed will be apparent to those of ordinary skill in the art in view ofthe teachings herein. It will also be appreciated that slits (490) mayhave any other suitable configuration (e.g., number of slits (490),depth of slits (490), length of slits (490), selection of which tubes(402, 404, 408, 410) have slits (490), etc.). Of course, slits (490) maysimply be omitted altogether.

Furthermore, one or more of tubes (402, 404, 408, 410) may be colored ortranslucent, such as to conceal blood that may be communicatedtherethrough.

-   -   H. Exemplary Motor Control

Vacuum control module (400) of the present example also includes acontroller (480) operable to control motors (246, 272, 282, 312, 322) inholsters (202, 302). For instance, a single controller (480) maycoordinate between motor functions on different motors (246, 272, 282,312, 322) that are within the same biopsy system (2). Vacuum controlmodule (400) includes a port (482) for providing communication of motorcontrol signals and power to motors (246, 272, 282, 312, 322) via acable (484). In other embodiments, motor control signals are providedwirelessly. While holster (202) of the present example has three motors(246, 272, 282) and holster (302) of the present example has two motors(312, 322), the same controller (480) and port (482) may be used tocontrol each holster (202, 302). Alternatively, each holster (202, 302)may have a respective dedicated port on vacuum control module (400).

Motors (246, 272, 282, 312, 322) may include any suitable combination ofbrushed or brushless technology. For instance, one or more of motors(246, 272, 282, 312, 322) may be a brushless motor that uses opticalcommutation. In some embodiments, the use of optical commutation mayprovide a degree of immunity to high ambient magnetic fields, such asthose that may be found in an MRI suite. A merely illustrative exampleof a motor using optical commutation is disclosed in U.S. Pat. No.5,424,625, entitled “Repulsion Motor,” issued Jun. 13, 1995, thedisclosure of which is incorporated by reference herein. Another merelyillustrative example of a motor using optical commutation is disclosedin U.S. Pat. No. 7,053,586, entitled “Brushless Repulsion Motor SpeedControl System,” issued May 30, 2006, the disclosure of which isincorporated by reference herein.

By way of example only, one or more of motors (246, 272, 282, 312, 322)may include an OPTEK OPR5005 reflective miniature surface mount opticalsource/detector sensor pair. Suitable sensors may include those that aretranmissive and/or those that are reflective. Furthermore, the lightthat is used may be coherent (e.g., LASER) or non-coherent (e.g.,generated by an LED). Either visible or invisible light spectra may beused. In the present example, a reflective infrared (IR) sensorcomprising an IR photodiode and an IR phototransistor is used. Theoptosensors are arrayed around the motor shaft in 120° increments in acircular array on a printed circuit board and in angular alignment withthe phase coils of the motor. A flag or optical interrupter that isaligned with magnets on the rotor is affixed to the motor shaft thattransmissive/non-reflective for half of its permiteter andreflective/non-transmissive over the other half. When the phase coilsare properly aligned with the optical sensors and the optical flag isproperly alighted with the magnetic poles on the rotor, a 60° positionsensing of the rotor is possible, just as it is with hall effectsensors. In addition, the logic level output from the optical sensorsmay be made identical to that of the hall effect sensors, allowinginterchangeability of sensing types with control hardware such ascontroller (480). Other suitable constructions for motors (246, 272,282, 312, 322), including those using optical commutation or otherwise,will be apparent to those of ordinary skill in the art in view of theteachings herein.

Controller (480) of the present example comprises a Magellan 4 axischipset from Performance Motion Devices, Inc. of Lincoln, Mass. In oneembodiment, controller (480) is configured to use hall effect signalsfor position-based control of any one of motors (246, 272, 282, 312,322). For instance, as noted above, motors (282, 322) of the presentexample are operationally coupled with encoder wheels (292) and sensors(296). Such a configuration may provide a three channel (A, B, and Indexpulse) quadrature encoder which, in combination with controller (480),permits repeatability of positioning manifold (144, 366) withinapproximately 0.1 degree.

In some embodiments hall effect sensors are used to provide bothcommutation and position control of at least one of motors (246, 272,282, 312, 322). Controller (480) is configured to provide a multiplexingscheme with signals provided by such hall effect sensors and thoseprovided by the sensor (296), whereby sixteen differential signals aremultiplexed onto either four or six differential lines that are coupledwith port (482) and effectively continued through cable (484). Ofcourse, any other suitable multiplexing scheme may be used, to theextent that any is used at all. Still other suitable configurations forand methods of operating through controller (480) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

VI. Exemplary Modes of Operation

It will be appreciated in view of the disclosure herein that there are avariety of methods by which biopsy system (2) may be operated. Forinstance, regardless of the structures or techniques that are used toselectively control communication of fluid (e.g., saline, vacuum,venting, etc.), through tubes (402, 404, 408, 410) or otherwise withinbiopsy system (2), there are a variety of timing algorithms that may beused. Such timing algorithms may vary based on an operational modeselected by a user. Furthermore, there may be overlap among operationalmodes (e.g., biopsy system (2) may be in more than one operational modeat a given moment, etc.). In addition to fluid communication timingalgorithms being varied based on a selected mode of operation, otheroperational aspects of biopsy system (2) may vary based on a selectedoperational mode. For instance, operation of tissue sample holder (140,368) may vary based on a selected operational mode, as may operation ofcutter (50) and other components of biopsy system (2). Several merelyexemplary operational modes will be described in greater detail below,while others will be apparent to those of ordinary skill in the art inview of the teachings herein.

A. Exemplary Presentation of Captured Tissue Samples

One merely exemplary operational mode may include a “view sample” mode.In this mode, manifold (144, 366) may be configured to rotate after atissue sample (4) is acquired, to present the tissue sample (4) to theoperator for viewing before the user acquires the next tissue sample. Inparticular, and as shown in FIG. 60, a tissue sample (4) is drawn intothe chamber (166, 388) that is in the twelve o'clock position when thetissue sample (4) is initially acquired. Manifold (144, 366) is thenrotated until the tissue sample (4) is at the three o'clock position,thereby permitting a user to easily view the tissue sample (4) from theside of biopsy device (100, 101). Such rotation may occur substantiallyimmediately after tissue sample (4) is drawn into chamber (166, 388).Alternatively, biopsy system (2) may “wait” to see if any user inputsoccur within a certain time period (e.g., 2 seconds) after tissue sample(4) has been acquired, then rotate the tissue sample (4) to the threeo'clock position only if no user inputs have occurred within that timeperiod.

The rotational position of manifold (144, 366) may be maintained suchthat tissue sample (4) is kept at the three o'clock position until someother user input is provided. For instance, if a user provides inputindicating a desire to obtain another tissue sample (4), biopsy system(2) may rotate manifold (144, 366) to align the next available chamber(166, 388) (e.g., a chamber (166, 388) that is immediately adjacent tothe chamber (166, 388) in which the most recently acquired tissue sample(4) resides) with cutter lumen (52). After the next available chamber(166, 388) has been aligned with cutter lumen (52), cutter (50) may beactivated to obtain another tissue sample (4), and an axial vacuum maybe used to draw this next tissue sample (4) into the next availablechamber (166, 388). If a “clear probe” or “aspirate” user input isprovided, manifold (144, 366) may be rotated to re-align the chamber(166, 388) in which tissue sample (4) resides with cutter lumen (52),and then the “clear probe” or “aspirate” control may be carried out asdescribed below. Similarly, if a “smart vac” cycle is initiated, whichwill be described in greater detail below, then manifold (144, 366) maybe rotated to re-align the chamber (166, 388) in which tissue sample (4)resides with cutter lumen (52), such that the “smart vac” cycle may becarried out.

An illustration of the rotation sequence of the present example isprovided in FIG. 60. As shown in block (600) tissue sample holder (140,368) is initially configured such that a first chamber (166, 388) is atthe twelve o'clock position. Then, as shown in block (602), a tissuesample (4) is communicated to the first chamber (166, 388). With the“view sample” mode activated, manifold (144, 366) then rotates such thatthe first chamber (166, 388) is at the three o'clock position, as shownin block (604). As shown in block (606), upon receiving user input toinitiate another sampling cycle, manifold (144, 366) is rotated to placea second chamber (166, 388) at the twelve o'clock position, such that atissue sample (4) is then communicated via cutter lumen (52) into thesecond chamber (166, 388). As shown in block (608), manifold (144, 366)then rotates such that the second chamber (166, 388) is at the threeo'clock position to present the second tissue sample (4) to the user. Asshown in block (610), the process of the present example repeats fortissue sample (4) acquisition in a third chamber (166, 388). Thisprocess may be repeated until all chambers (166, 388) within tissuesample holder (140, 368) are full.

As an alternative to waiting for a user input, tissue sample (4) may bekept in the three o'clock position for a certain time period (e.g., 5seconds), with the manifold (144, 366) being automatically rotated toalign the next available chamber (166, 388) with cutter lumen (52),regardless of whether a user has provided an input. As anothernon-limiting variation, biopsy system (2) may keep tissue sample (4) inthe three o'clock position only for such a time period, unless the userhas provided some type of input before the expiration of that timeperiod, which would cause manifold (144, 366) to be rotated as notedabove. Still other ways in which timing and/or user inputs may be usedto determine the duration for which a tissue sample (4) is kept in thethree o'clock position will be apparent to those of ordinary skill inthe art in view of the teachings herein. It will also be appreciatedthat such rotational control of manifold (144, 366) may be carried outat least in part by controller (480), in combination with feedback fromencoder wheel (292) and sensor (296), or using any other suitablecomponents.

Biopsy system (2) may also be configured to permit a user to select thenine o'clock position (or any other position) for presentation of tissuesample (4) in lieu of the three o'clock position noted above. Biopsysystem (2) may also permit a user to disable the “view sample” mode,such that the only rotation of manifold (144, 366) between acquisitionof tissue samples (4) is to align a next available chamber (166, 388)with cutter lumen. Other variations of biopsy system (2) may lack a“view sample” mode or similar mode, as well as components that might beused for such a mode, altogether.

-   -   B. Exemplary “Sample” Cycle

Another exemplary operational mode, which may overlap with the “viewsample” mode discussed above, is a sampling mode, during which a“sample” cycle may be initiated. An exemplary sequence of cutter (50)position within outer cannula (12), relative to fluid communicationprovided through tubes (402, 404), in a “sample” cycle is shown in FIG.61. This cycle is initiated after needle portion (10) has been insertedinto the breast of a patient. With needle portion (10) inserted, lateraland axial vacuum are applied. In particular, solenoids (456) areactivated such that tips (476, 478) are moved upward to substantiallydisengage tubes (402, 404), permitting a vacuum to be communicatedthrough tubes (402, 404). Given the fluid connection of tube (402) withneedle manifold (80, 366), as well as the transverse openings (32)formed through wall (30), communication of a vacuum through tube (402)will draw a lateral vacuum relative to cannula lumen (20). Communicationof a vacuum through tube (404) will draw an axial vacuum through cutterlumen (52), given the fluid connection of tube (404) to cutter lumen(52) via tissue sample holder (140, 368) in this example.

With the axial and lateral vacuum applied as described above, cutter(50) is retracted axially. Such axial retraction is performed usingmotor (272, 312) and cutter rotation and translation mechanism (120) asdescribed above. The axial retraction of cutter (50) will serve to“open” aperture (16), which results in tissue prolapsing into aperture(16) under the influence of the above-described vacuums. Cutter (50) maydwell in a retracted position for a certain period of time to ensuresufficient prolapse of tissue.

Next, cutter (50) is advanced distally to sever tissue that is prolapsedthrough aperture (16). Such advancement may be accomplished by simplycausing motor (272, 312) to rotate in the direction opposite to thedirection in which motor (272, 312) rotated during retraction of cutter(50). In some embodiments, vacuum lumen (40) is switched from vacuum tosaline as cutter (50) advances. For instance, solenoids (456) may movetip (478) downward to pinch tube (402), thereby preventing furthercommunication of vacuum through tube (402); and may move tip (472)upward to substantially disengage tube (408), thereby permittingcommunication of saline through tubes (408, 402). In some otherembodiments, vacuum lumen (40) is switched from vacuum to vent as cutter(50) advances. For instance, solenoids (456) may move tip (478) downwardto pinch tube (402), thereby preventing further communication of vacuumthrough tube (402); and may move tip (474) upward to substantiallydisengage tube (410), thereby permitting venting (e.g., into atmosphere)through tubes (408, 402). In still other embodiments, vacuum lumen (40)alternates between saline and venting. An axial vacuum continues to becommunicated through cutter lumen (52) as cutter (50) is advanced.

As the distal end of cutter (50) passes the distal edge of aperture(16), such that cutter (50) “closes” aperture (16), the prolapsed tissueshould be severed and at least initially contained within cutter lumen(52). Transverse openings (32) should be configured such that at leastone or more of transverse openings (32) are not covered by cutter (50)when cutter (50) has reached a position to “close” aperture (16). Withaperture (16) closed and a vent being provided by transverse openings(32) through tube (402), an axial vacuum being communicated throughcutter lumen (52) by tube (404) should draw the severed tissue sample(4) proximally through cutter lumen (52) and into a chamber (166, 388)of tissue sample holder (140, 368). Cutter rotation and translationmechanism (120) may also be controlled to cause cutter (50) toreciprocate one or more times through a slight range of motion at adistal position to sever any remaining portions that may have not beencompletely severed in the first pass of cutter (50).

Before tissue sample (4) is communicated proximally through cutter lumen(52), with aperture (16) being closed by cutter (50), vacuum lumen (40)being vented by tubes (402, 410), and an axial vacuum being provided bytube (404) via cutter lumen (52), cutter (50) is retracted slightly toexpose a portion of aperture (16) for a short period of time. Duringthis time, saline may be provided at atmospheric pressure to vacuumlumen (40) by tubes (402, 408). Further retraction of cutter (50)exposes more transverse openings (32), thereby increasing fluidcommunication between vacuum lumen (40) and cannula lumen (20).Retraction of cutter (50) also exposes the pressure of the tissue cavity(from which tissue sample (4) was obtained) to the distal surface oftissue sample (4). As a result of the slight retraction of cutter (50)in this particular example, the likelihood of atmospheric pressure beingapplied to the distal face of tissue sample (4) may be increased to helpensure that severed tissue sample (4) does not remain in needle portion(10) (a.k.a. a “dry tap”). Cutter (50) is then fully advanced distally,closing both aperture (16) and all transverse openings (32). Such“closure” of transverse openings (32) may ensure that if medication isapplied at this time (between samples) to reduce pain, it will reach thebreast cavity through external openings (22) instead of being aspiratedthrough transverse openings (32) and through cutter lumen (52) andtissue sample holder (140, 368).

With the cutter (50) being completely advanced (e.g., such that alltransverse openings (32) and aperture (16) are closed), and severedtissue sample (4) being communicated proximally through cutter lumen(52) and into a chamber (166, 388) by an axial vacuum drawn by tube(404), biopsy device (100, 101) will be in a ready state. In this readystate, vacuum lumen (40) is vented to atmosphere, and axial vacuum tube(404) is sealed (a.k.a. “dead-headed”). In other words, tip (472) ispinching saline tube (408) to prevent fluid communication therethrough,tip (474) is substantially disengaged from vent tube (410) to permitventing to atmosphere therethrough, tip (476) is pinching axial vacuumtube (404) to prevent fluid communication therethrough, and tip (478) ispinching lateral vacuum tube (402) to prevent fluid communicationtherethrough. In this ready state, biopsy device (100, 101) is ready toobtain another tissue sample (4), such as by initiating another samplingsequence as described above.

It will be appreciated that a “sample” cycle may be carried out in avariety of alternative ways. For instance, motion of cutter (50) mayvary during the process of acquiring a tissue sample. Furthermore, thetiming of, sequence of, and interrelationships between lateral vacuum,axial vacuum, venting, and saline may be varied in a number of ways.Accordingly, the inventors contemplate a host of other permutations ofsuch variables, and do not consider the invention to be limited in anyway to the merely illustrative permutations explicitly discussed indetail above.

C. Exemplary “Clear Probe” Cycle

It will be appreciated that, at some point during use of biopsy device(100, 101), biopsy device (100, 101) may exhibit signs of being jammedwith tissue or other debris. Such signs will be apparent to those ofordinary skill in the art in view of the teachings herein. During suchtimes, or otherwise, it may be desirable to initiate a sequence that mayclear such tissue or debris in order to improve the performance ofbiopsy device (100, 101). To that end, biopsy system (2) may permit a“clear probe” cycle to be initiated. A merely exemplary “clear probe”cycle will be described in detail below, while other variations of a“clear probe” cycle will be apparent to those of ordinary skill in theart in view of the teachings herein. FIG. 62 depicts an exemplarysequence of the position of cutter (50) within needle portion (10),relative to fluid communication being provided through tubes (402, 404),in an exemplary “clear probe” cycle.

If the “clear probe” cycle of the present example is initiated whilebiopsy system (2) is in a “view sample” mode as described above,manifold (144, 366) will be rotated move chamber (166, 388) from thethree o'clock (or nine o'clock) position back to the twelve o'clockposition. If biopsy system (2) is not in a “view sample” mode when the“clear probe” cycle of the present example is initiated, then manifold(144, 366) is not rotated. Next, cutter (50) retracts slightly to exposea portion of aperture (16) for a short period of time. During thisperiod of exposure, air and/or saline (at atmospheric pressure) iscommunicated via tube (402). Also during this time, vacuum is providedthrough tube (404). Cutter (50) then advances to close aperture (16)without covering all of transverse openings (32). This same cycle isrepeated additional times (e.g., one to four additional times, etc.) tocomplete the “clear probe” cycle. After the “clear probe” cycle iscompleted, biopsy system (2) enters a ready state. To the extent that anext “sample” cycle is not initiated within a certain amount of time(e.g., a few seconds, etc.), the “view sample” mode may be reactivateduntil the next “sample” cycle is initiated.

It will be appreciated that a “clear probe” cycle may be carried out ina variety of alternative ways. For instance, motion of cutter (50) mayvary during the process of clearing a probe (102, 103). Furthermore, thetiming of, sequence of, and interrelationships between lateral vacuum,axial vacuum, venting, and saline may be varied in a number of ways.Accordingly, the inventors contemplate a host of other permutations ofsuch variables, and do not consider the invention to be limited in anyway to the merely illustrative permutations explicitly discussed indetail above.

D. Exemplary “Position” Cycle

FIG. 63 depicts an exemplary sequence of the position of cutter (50)within needle portion (10), relative to fluid communication beingprovided through tubes (402, 404), in an exemplary “position” cycle. Ifa “position” cycle is initiated when aperture (16) is closed (e.g., whencutter (50) is advanced to a distal position) and when biopsy device(100, 101) is in a ready state, then cutter (50) is retractedproximally. During this time, tube (402) continues to be vented toatmosphere and tube (404) is sealed (a.k.a. dead-headed) by beingpinched by tip (476).

A “position” cycle may be used in a variety of contexts. For instance,during an ultrasound guided procedure or other procedure, a needle (10)may be inserted into tissue with aperture (16) closed. To confirm thelocation of aperture (16) within the tissue, a “position” cycle may beinitiated to open the aperture (16) to aid in visualizing the aperture(16). Once the aperture (16) location is confirmed, a “position” cyclemay be initiated to close aperture (16). Another application of a“position” cycle may be when a marker is to be deployed into the tissuethrough cutter lumen (52) and into the tissue via aperture (16). In thiscontext, a “position” cycle may be initiated to open aperture (16) toallow the tissue marker to be deployed into tissue via the open aperture(16). Other suitable uses for a “position” cycle will be apparent tothose of ordinary skill in the art in view of the teachings herein.

If a “position” cycle is initiated when aperture (16) is open (e.g.,when cutter (50) is retracted to a proximal position) and when biopsydevice (100, 101) is in a ready state, then cutter (50) is advanceddistally to close aperture (16). During this time, tube (402) continuesto be vented to atmosphere and tube (404) is sealed (a.k.a. dead-headed)by being pinched by tip (476).

A variation of the “position” cycle may be used to vary the size ofaperture (16) with cutter (50) in a manner such that aperture (16) willnot open further than a preselected size during a “sample” cycle. Forinstance, it may be desirable to “shorten” the length of aperture (16)in order to acquire tissue samples (4) of a relatively shorter length,to acquire tissue samples (4) that are relatively close to the surfaceof a patient's skin, or for other purposes. Exemplary uses of cutter(50) position to vary the size of an aperture (16) during acquisition oftissues samples (4) are disclosed un U.S. Pub. No. 2006/0200040,entitled “Biopsy Device with Variable Side Aperture,” published Sep. 7,2006, the disclosure of which is incorporated by reference herein. Aswill be described in greater detail below, user interfaces (700, 800)may be used to variably select the degree to which aperture (16) may beopened during a “sample” cycle.

It will be appreciated that a “position” cycle may be carried out in avariety of alternative ways. For instance, motion of cutter (50) mayvary during the process of positioning a cutter (50). Furthermore, thetiming of, sequence of, and interrelationships between lateral vacuum,axial vacuum, venting, and saline may be varied in a number of ways.Accordingly, the inventors contemplate a host of other permutations ofsuch variables, and do not consider the invention to be limited in anyway to the merely illustrative permutations explicitly discussed indetail above.

E. Exemplary “Aspirate” Cycle

It may be desirable to remove fluids from a biopsy site during a biopsyprocedure. Accordingly, biopsy system (2) of the present exampleincludes an “aspirate” cycle, which may be used to remove such fluids orfor other purposes. FIG. 64 depicts an exemplary sequence of theposition of cutter (50) within needle portion (10), relative to fluidcommunication being provided through tubes (402, 404), in an exemplary“aspirate” cycle.

If the “aspirate” cycle of the present example is initiated while biopsysystem (2) is in a “view sample” mode as described above, manifold (144,366) will be rotated move chamber (166, 388) from the three o'clock (ornine o'clock) position back to the twelve o'clock position. If biopsysystem (2) is not in a “view sample” mode when the “aspirate” cycle ofthe present example is initiated, then manifold (144, 366) is notrotated. Next, as an aspirate button (not shown) is being actuated, oras some other user input is being provided, cutter (50) retracts untilsuch actuation or input ceases. Thus, the longer the button is depressedor other input is provided, the more of aperture (15) is exposed bycutter (50). In addition, as the aspirate button is actuated or someother user input is provided, vacuum is provided through both of tubes(402, 404). Such vacuum is thus communicated axially through cutterlumen (52), and laterally (relative to cannula lumen (20)) throughtransverse openings (32). It will be appreciated that, with aperture(16) being at least partially open, vacuum provided through tubes (402,404) may serve to draw fluids from the biopsy site. Such fluids will bedeposited in vacuum canister (500) in the present example.

When the aspirate button is released, or similar user input ceases orchanges, tube (402) may be switched from providing a lateral vacuum toproviding a vent. In other words, solenoids (456) may be activated suchthat tip (478) substantially engages tube (402) to prevent furthercommunication of a vacuum through tube (402), and such that tip (474)substantially disengages tube (410) to permit venting through tubes(410, 402). In addition, tube (404) is sealed (a.k.a. dead-headed) atthis time, such as by tip (476) substantially engaging tube (404) toprevent further communication of a vacuum through tube (402). After abrief pause (e.g., a few seconds), cutter (50) is completely advanceddistally, closing aperture (16) and covering transverse openings (32).Biopsy device (100, 101) is then again in a ready state.

If aperture (16) was open (e.g., cutter (50) at least partiallyretracted) when the “aspirate” cycle was initiated, then aperture (16)will remain open during the “aspirate” cycle, and vacuum is providedthrough tubes (402, 404) during the duration of the aspirate buttonbeing actuated (or during the duration of some other user input beingprovided). Once the aspirate button is released (or the other user inputceases or changes), then aperture (16) remains open, and biopsy device(100, 101) is again in a ready state. Accordingly, cutter (50) need notmove during an “aspirate” cycle.

It will be appreciated that a “aspirate” cycle may be carried out in avariety of alternative ways. For instance, motion of cutter (50) mayvary during the process of aspirating through a probe (102, 103).Furthermore, the timing of, sequence of, and interrelationships betweenlateral vacuum, axial vacuum, venting, and saline may be varied in anumber of ways. Accordingly, the inventors contemplate a host of otherpermutations of such variables, and do not consider the invention to belimited in any way to the merely illustrative permutations explicitlydiscussed in detail above.

F. Exemplary “Smart Vac” Cycle

There may be situations that arise during use of biopsy system (2) whenneedle portion (10) remains inserted in a patient's breast withouttissue samples (4) being taken for a certain period of time. It may bedesirable to remove fluids from a biopsy site during such periods.Accordingly, biopsy system (2) of the present example includes a “smartvac” cycle, which may be used to periodically remove such fluids duringsuch periods or for other purposes. FIG. 65 depicts an exemplarysequence of the position of cutter (50) within needle portion (10),relative to fluid communication being provided through tubes (402, 404),in an exemplary “smart vac” cycle.

A “smart vac” cycle of the present example may be initiated when biopsysystem (2) has been in a ready state for an extended period of time(e.g., one minute, thirty seconds, other periods of time, etc.) withoutany user inputs having been provided during such time. Such a period ofdormancy may cause a “smart vac” cycle to be initiated automatically,whereby cutter (50) retracts slightly to expose a portion of aperture(16) during a short period of time (e.g., a few seconds). With cutter(50) slightly retracted, vacuum is applied through tubes (402, 404) toremove fluids from the biopsy site. Cutter (50) then automaticallyadvances to close off aperture (16), and biopsy system (2) returns to aready state. The “smart vac” cycle again automatically repeats if nofurther user inputs are provided within a certain period of time afterthe first “smart vac” cycle is completed. This process may be repeatedindefinitely.

In an alternate embodiment, the level of vacuum may be lower during a“smart vac” cycle then it is during other operational cycles. Such alower vacuum level may be provided in a variety of ways. For instance,tips (476, 478) may partially pinch tubes (402, 404) to restrict but notcut off fluid communication through tubes (402, 404). Alternatively,operation of vacuum pump (440) may be modified to adjust vacuum levelsinduced by vacuum pump (440). Other ways in which a vacuum level may bevaried will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

It will be appreciated that a “smart vac” cycle may be carried out in avariety of alternative ways. For instance, motion of cutter (50) mayvary during the process of removing fluids from a biopsy site.Furthermore, the timing of, sequence of, and interrelationships betweenlateral vacuum, axial vacuum, venting, and saline may be varied in anumber of ways. Accordingly, the inventors contemplate a host of otherpermutations of such variables, and do not consider the invention to belimited in any way to the merely illustrative permutations explicitlydiscussed in detail above.

VII. Exemplary User Interface on Vacuum Control Module

As discussed above, display screen (702), switches (704), and speaker(706) may be regarded as collectively forming user interface (700). Inaddition, as also discussed above, face portion (420) is configured suchthat display screen (702) can be viewed therethrough; such thatcapacitive switches (704) may be activated therethrough; and such thatsounds coming from the speaker (706) can be heard therethrough.Capacitive switches (704) are configured such that switches (704) areactivated when a user's finger comes in close enough proximity toswitches (704). In particular, a capacitive switch (704) may generate anelectrical field, such that the approaching finger of a user may cause adisturbance in the electrical field that may be detected by theapproached switch (704). Capacitive switches (704) may have sufficientsensitivity such that a user need not even touch face portion (420) inorder to activate a capacitive switch (704). In other words, capacitiveswitches (704) may be configured such that a user's finger need onlyreach certain distance from face portion (420) over capacitive switches(704) in order to activate switches (704). Of course, any other suitable“touch-free” technology (e.g., ultrawideband radar, etc.) may be used inlieu of or in addition to capacitive switches (704). Alternatively,other input devices (e.g., conventional buttons, switches, sliders,dials, etc.) may be used.

Capacitive switches (704) of the present example are supplemented withLEDs (not shown). In particular, an LED is positioned with respect toeach capacitive switch (704) to provide visual feedback when theassociated capacitive switch (704) is sufficiently activated by a user.For instance, an LED associated with each capacitive switch (704) mayremain lit by default, and may switch to unlit when its associatedcapacitive switch (704) has been sufficiently activated. Alternatively,an LED associated with each capacitive switch (704) may remain unlit bydefault, and may switch to lit when its associated capacitive switch(704) has been sufficiently activated. An LED may also be used toprovide visual feedback as to the state of vacuum control module (400).For instance, a status LED may stay constantly lit as vacuum controlmodule (400) is running, and may pulse (e.g., ebb and intensify) whenvacuum control module (400) is in a “sleep mode” (e.g., powered-on butnot being actively used). Other ways in which LEDs or other lightsources or visual indicators may be incorporated into vacuum controlmodule, either in conjunction with capacitive switches (704) orotherwise, will be apparent to those of ordinary skill in the art inview of the teachings herein.

In addition, speaker (706) may emit auditory tones to reinforce feedbackassociated with use of vacuum control module (400). For instance,speaker (706) may emit a tone when a capacitive switch (704) has beenactivated. In addition, certain switches (704) may have certain tones orauditory patterns associated with them. Similarly, certain selectionsmade by a user activating switches (704), such as the selections andoperations described in greater detail below, may each have a distinct,associated tone or auditory pattern. Of course, auditory tones orpatterns, or other uses for speaker (706), may be incorporated intovacuum control module (400) and use of the same in a variety ofalternative ways.

Other aspects of user interface (700) are shown in FIGS. 66-68. Inparticular, FIGS. 66-68 show a variety of exemplary screens (720, 740,760) that may be displayed on display screen (702). Each of these merelyexemplary screens (720, 740, 760) will be described in greater detailbelow. In one embodiment, face portion (420) and display screen (702)configured such that the perimeter of display screen (702) cannot beseen through face portion (420). Furthermore, face portion (420) doesnot provide any definition for a perimeter associated with displayscreen (702). Thus, text, icons, and other visual indicia displayed ondisplay screen (702) appears to “float” on the face of vacuum controlmodule (400). Of course, such a configuration is merely optional.

As is also shown in FIGS. 66-68, capacitive switches (704) are visuallypresented as buttons (708, 710), which are vertically aligned adjacentto screens (720, 740, 760). Buttons (708, 710) include a top button(708), which is used to cycle between the various screens (720, 740,760); and lower buttons (710), which are used to provide inputselections relative to an active screen (720, 740, 760). In particular,each time top button (708) is activated, such activation causes displayscreen (702) to change from one screen (720, 740, 760) being active tothe next screen (720, 740, 760) being active.

Each screen (720, 740, 760) has a corresponding tab (722, 740, 762)associated therewith. In particular, a “Status” tab (722) is associatedwith a status screen (720), a “Probe” tab (742) is associated with aprobe screen (740), and a “System” tab (762) is associated with a systemscreen (760). Tabs (722, 740, 762) are arranged at the top of eachcorresponding screen (720, 740, 760), and the tabs (722, 740, 762) ofother screens (720, 740, 760) can still be seen when a given screen(720, 740, 760) is active. For instance, in FIG. 66, the status screen(720) is active, yet the “Probe” tab (742) and “System” tab (762) maystill be seen. However, the “Status” tab (722) is more brightly lit thanthe “Probe” tab (742) and “System” tab (762) in FIG. 66. In FIG. 67, theprobe screen (740) is active; while in FIG. 68, the system screen (762)is active. It will be appreciated by those of ordinary skill in the artin view of the teachings herein that tabs (722, 740, 762) are merelyexemplary, and that tabs (722, 740, 762) may be incorporated into a userinterface (700) in a variety of alternative ways. In addition, there area variety of alternative features that may be used in addition to or inlieu of tabs (722, 740, 762).

A. Exemplary “Status” Screen

Referring back to FIG. 66, a merely exemplary status screen (720)includes several visual indicators (724, 726, 728, 730). For instance, a“view sample” indicator (724) indicates whether biopsy system (2) is in“view sample” mode, examples of which are described in greater detailabove. As shown, the “view sample” indicator (724) of this exampleincludes an icon shown as a circle with a slash to indicate that the“view sample” mode is turned off. A checkmark or other indication may beused to indicate when the “view sample” mode is turned on. A user mayturn the “view sample” mode on or off when the probe screen (740) isactive, as will be described in greater detail below. Of course, othersuitable visual indicators may be used in addition to or in lieu of thecircle with a slash and/or checkmark to indicate the status of the “viewsample” mode.

A “vacuum level” indicator (726) is also provided on status screen(720). As shown, the “vacuum level” indicator (726) of this exampleincludes an icon shown as a set of ascending bars, to indicate thevacuum level of biopsy system (2). A user may adjust the vacuum level ofbiopsy system (2) when the system screen (760) is active, as will bedescribed in greater detail below. Incremental increases in the vacuumlevel are indicated in this example by the illumination of an additionalbar in the set of ascending bars of “vacuum level” indicator (726). Inother words, the number of bars that are illuminated in “vacuum level”indicator (726) will be indicative of the vacuum level of biopsy system(2). Of course, any other suitable visual indicators (e.g., a simulatedneedle gauge, a number, etc.) may be used in addition to or in lieu ofascending bars to indicate the level of vacuum within biopsy system (2).

A “needle aperture” indicator (728) is also provided on status screen(720). As shown, the “needle aperture” indicator (726) of this exampleincludes an icon shown as a needle end with a brightly lit cutter. This“needle aperture” indicator (726) may be used to indicate the maximumdistance to which cutter (50) will be retracted within needle portion(10) during use of biopsy system (2). For instance, as noted above inthe context of a “position” cycle, a user may wish to restrict proximalmovement of cutter (50) to restrict the degree to which aperture (16)will be opened within a breast. Such use of a cutter (50) to vary theaperture (16) opening for a biopsy procedure is described in U.S. Pub.No. 2006/0200040, entitled “Biopsy Device with Variable Side Aperture,”published Sep. 7, 2006, the disclosure of which is incorporated byreference herein. A user may adjust this effective needle aperture (16)when the probe screen (740) is active, as will be described in greaterdetail below. The position of the cutter portion of the icon in the“needle aperture” indicator (726) relative to the needle portion of theicon in the “needle aperture” indicator (726) may be indicative of theeffective needle aperture (16) set by a user. Of course, any othersuitable visual indicators may be used in addition to or in lieu of arendering of a needle and cutter end to indicate the effective needleaperture set by a user.

A “smart vac pulse” indicator (730) is also provided on status screen(720), to indicate whether biopsy system (2) is in “smart vac” mode asdescribed in greater detail above. As shown, the “smart vac pulse”indicator (730) of this example includes an icon shown as checkmark toindicate that the “smart vac pulse” mode is turned on. A circle with aslash or other indication may be used to indicate when the “smart vacpulse” mode is turned off A user may turn the “smart vac” mode on or offwhen the probe screen (740) is active, as will be described in greaterdetail below. Of course, other suitable visual indicators may be used inaddition to or in lieu of the circle with a slash and/or checkmark toindicate the status of the “smart vac” mode.

In view of the foregoing, status screen (720) of the present example isused merely to indicate the status of several variables within biopsysystem (2). Status screen (720) of this particular example is notconfigured to accept user inputs to change any of these variables orotherwise alter the operation of biopsy system (2). Buttons (710) arenot active when status screen (720) is active. In order to change any ofthe variables, a user must activate top button (708) in status screen(720) in order to switch active screens from status screen (720) toprobe screen (740) or system screen (760), where the user may thenprovide inputs to change variables. In other embodiments, however, astatus screen (720) may permit a user to change some or all variableswhose status is indicated on status screen (720). Other ways in which astatus screen (720) or other screen may be provided will be apparent tothose of ordinary skill in the art in view of the teachings herein. Inaddition, in some embodiments, a status screen (720) is simply omittedaltogether (e.g., such that only a probe screen (740) and system screen(760) and/or other screens are used, etc.).

B. Exemplary “Probe” Screen

Referring back to FIG. 67, a merely exemplary probe screen (740)includes several visual indicators (744, 746, 748, 750). For instance,an “aperture” indicator (742) indicates the maximum distance to whichcutter (50) will be retracted within needle portion (10) during use ofbiopsy system (2). For instance, as noted above, a user may wish torestrict proximal movement of cutter (50) to restrict the degree towhich aperture (16) will be opened within a breast. A user may adjustthis effective needle aperture (16) by activating the button (710) thatis next to the “aperture” indicator (742). Each time the user activatesthis button (710), biopsy system (2) will make a correspondingadjustment to the effective needle aperture (16), such as throughcontroller (480). Such adjustments may be incremental, such as toprovide an aperture (16) that is 50%, 75%, or 100% open, though otherincrements may be used. In addition, each time the user activates thisbutton (710), the cutter portion of the icon in the “aperture” indicator(742) moves relative to the needle portion of the icon in the “aperture”indicator (742). Arrows are also shown above the needle portion of theicon to emphasize the maximum proximal position of the needle selectedby the user. Furthermore, a text representation (e.g., “Sm” for smallaperture (16), “Lg” for large aperture, etc.) may be included to furtherindicate the effective aperture (16) size selected by the user.

It will be appreciated in view of the teachings herein that “aperture”indicator (742) on probe screen (740) is similar to “needle aperture”indicator (728) on status screen (720), except that “aperture” indicator(742) on probe screen (740) provides additional information on theeffective aperture (16) length selected by the user. Furthermore, unlikestatus screen (720) in the present example, probe screen (740) permitsthe user to adjust the effective aperture (16) length by activating thebutton (710) that is next to “aperture” indicator (742). Each activationof button (710) by the user may result in an incrementally decreasedeffective aperture (16) length, until the length reaches zero, at whichtime a subsequent activation of button (710) may result in the length“flipping back” to the full aperture (16) length. As an alternative topermitting incremental changes in effective aperture (16) length, userinterface (700) may permit a user to gradually change the effectiveaperture (16) length, such as by using a slider, dial, knob, etc.,including by use of touch-sensitive virtual representations (e.g., on atouch-sensitive screen) of such input devices. Other ways in which auser may be permitted to adjust effective aperture (16) length will beapparent to those of ordinary skill in the art in view of the teachingsherein. In addition, any other suitable visual indicators may be used inaddition to or in lieu of a rendering of a needle and cutter end toindicate the effective needle aperture set by a user.

Probe screen (740) of the present example also includes a “view sample”indicator (746), which indicates whether biopsy system (2) is in “viewsample” mode as described above. As shown, the “view sample” indicator(746) of this example includes an icon shown as a circle with a slash toindicate that the “view sample” mode is turned off To turn the “viewsample” mode on, the user may activate the button (710) next to the“view sample” indicator (746). A checkmark or other icon or indicatormay replace the circle with a slash to indicate that the “view sample”mode has been turned on. To turn the “view sample” mode back off, theuser may activate the button (710) next to the “view sample” indicator(746) again.

It will be appreciated in view of the teachings herein that “viewsample” indicator (746) on probe screen (740) is similar to “viewsample” indicator (724) on status screen (720), except that probe screen(740) permits the user to turn the “view sample” mode on and off byactivating the button (710) that is next to “view sample” indicator(746). Of course, other suitable visual indicators may be used inaddition to or in lieu of the circle with a slash and/or checkmark toindicate the status of the “view sample” mode.

Probe screen (740) of the present example also includes a “revolverreset” indicator (748), which indicates that the button (710) that isnext to the “revolver reset” indicator (748) may be activated to resetthe manifold (144, 366) position. In particular, as noted above, encoderwheel (292) and sensor (296) are used in some embodiments to track therotational position of manifold (144, 366) during use of biopsy device(100, 101). When a user has replaced manifold (144, 366), such that thelast chamber (166, 388) that biopsy system (2) “thinks” is aligned withcutter lumen (52) is no longer aligned with cutter lumen (52), the usermay activate the button (710) that is next to the “revolver reset”indicator (748) to indicate to biopsy system (2) that a new manifold(144, 366) has been coupled with probe (102, 103). Biopsy system (2)will then “assume” that the predefined chamber (166, 388), or thepassage (158) is aligned with cutter lumen (52). The button (710) thatis next to the “revolver reset” indicator (748) may also be activatedunder other conditions, such as when a user has manually rotatedmanifold (144, 366) to align the predefined chamber (166, 388) withcutter lumen (52).

Probe screen (740) of the present example also includes a “smart vacpulse” indicator (750), which indicates whether biopsy system (2) is in“smart vac” mode as described in greater detail above. As shown, the“smart vac pulse” indicator (750) of this example includes an icon shownas checkmark to indicate that the “smart vac pulse” mode is turned on. Acircle with a slash or other indication may be used to indicate when the“smart vac pulse” mode is turned off To turn the “smart vac” mode off,the user may activate the button (710) next to the “smart vac pulse”indicator (750). A circle with a slash or other icon or indicator mayreplace the checkmark to indicate that the “smart vac” mode has beenturned off. To turn the “smart vac” mode back on, the user may activatethe button (710) next to the “smart vac pulse” indicator (750) again.

It will be appreciated in view of the teachings herein that “smart vacpulse” indicator (750) on probe screen (740) is similar to “smart vacpulse” indicator (730) on status screen (720), except that probe screen(740) permits the user to turn the “smart vac” mode on and off byactivating the button (710) that is next to “smart vac pulse” indicator(750). Of course, other suitable visual indicators may be used inaddition to or in lieu of the circle with a slash and/or checkmark toindicate the status of the “smart vac” mode.

C. Exemplary “System” Screen

Referring back to FIG. 68, a merely exemplary system screen (760)includes several visual indicators (764, 766, 768, 770). For instance, a“vacuum level” indicator (764) is provided on system screen (760). Asshown, the “vacuum level” indicator (764) of this example includes anicon shown as a set of ascending bars, to indicate the vacuum level ofbiopsy system (2). To adjust the vacuum level of biopsy system (2), theuser may activate the button (710) next to the “vacuum level” indicator(764). Each time the user activates this button (710), the vacuum levelof biopsy system (2) may increase incrementally. Such incrementalincrease may be indicated by illuminating an additional bar in the setof ascending bars of “vacuum level” indicator (764). In other words, thenumber of bars that are illuminated in “vacuum level” indicator (764)will be indicative of the vacuum level of biopsy system (2).

If the user activates the associated button (710) when all of the barsare illuminated (e.g., which may indicate that the vacuum level is atits highest), the level of vacuum may be significantly decreased to thelowest level, such that only the first bar in the set of bars isilluminated. Thus, a user may cycle through various incremental vacuumlevels by repeatedly activating the button (710) that is next to the“vacuum level” indicator (764), and these incremental changes in thevacuum level may be indicated in the set of ascending bars of the“vacuum level” indicator (764).

It will be appreciated that control of vacuum level, as selected by auser via the system screen (760), may be effected in a variety of ways.For instance, the selected vacuum level may be effected by changing theoperation of vacuum pump (440). Alternatively, the selected vacuum levelmay be effected by changing the degree to which tips (476, 478)disengage tubes (402, 404) when a vacuum is to be applied through tubes(402, 404). For instance, solenoids (456) may be activated to releasetips (476, 478) from tubes only slightly, such that tips (476, 478)create a restriction in tubes (402, 404) without preventing a vacuumfrom being communicated through tubes (402, 404). In another variation,an additional valve (not shown) or other component at any suitablelocation is used to vary the vacuum level in accordance with a user'sselections.

It will be appreciated in view of the teachings herein that “vacuumlevel” indicator (764) on system screen (760) is similar to “vacuumlevel” indicator (764) on status screen (720), except that system screen(760) permits the user to change the vacuum level of biopsy system (2)by activating the button (710) that is next to “vacuum level” indicator(764). Of course, any other suitable visual indicators (e.g., asimulated needle gauge, a number, etc.) may be used in addition to or inlieu of ascending bars to indicate the level of vacuum within biopsysystem (2).

System screen (760) of the present example also includes a “volume”indicator (766). As shown, the “volume” indicator (766) of this exampleincludes an icon shown as a speaker and a set of bars that increase insize, to indicate the volume level of tones that will be emitted byspeaker (706). To adjust the volume, the user may activate the button(710) that is next to the “volume” indicator (766). Each time the useractivates this button (710), the volume may increase incrementally. Suchincremental increase may be indicated by illuminating an additional barin the set of ascending bars of “volume” indicator (766). In otherwords, the number of bars that are illuminated in “volume” indicator(766) will be indicative of the volume of tones or other sounds thatwill be emitted by speaker (706). “Volume” indicator (766) and itsassociated button (710) are thus similar to “vacuum level” indicator(764) and its associated button (710) as described above, with theexception that the former are associated with volume levels while thelatter are associated with vacuum levels. Of course, any other suitablevisual indicators (e.g., a simulated dial, a number, etc.) may be usedin addition to or in lieu of a speaker and bars that increase in size toindicate the volume level.

System screen (760) of the present example also includes a “standby”indicator (768). As shown, the “standby” indicator (768) of this exampleincludes an icon shown as a star and a moon. To put biopsy system (2) ina standby mode, the user may activate the button (710) that is next tothe “standby” indicator (768). In one version of standby mode, vacuumpump (440) is turned off, and at least some user input devices aredeactivated (e.g., user interface (800) on holster (202, 302), afootswitch, etc.). Other variations of a standby mode will be apparentto those of ordinary skill in the art in view of the teachings herein.In order to bring biopsy system (2) out of standby mode, a user maysimply activate any capacitive switch (704) at user interface (700),activate any switch or button on holster (202, 302), or perform someother action.

System screen (760) of the present example also includes a “shutdown”indicator (770). As shown, the “shutdown” indicator (770) of thisexample includes an icon representative of a power button. To shutbiopsy system (2) down, the user may activate the button (710) that isnext to the “shutdown” indicator (770). Of course, there are a varietyof other ways in which a user may be permitted to shut biopsy system (2)down.

While not shown in the accompanying drawings, it will be appreciatedthat display screen (702) may display a variety of other displays notexplicitly described above. By way of example only, when cable (484) isnot connected to port (482), display screen (702) may display a messageinstructing the user to connect cable (484). Similarly, when vacuumcanister (500) is not inserted into canister compartment (458), or if asatisfactory seal is not obtained between vacuum ports (462, 514),display screen (702) may display a message instructing the user toproperly insert vacuum canister (500) into canister compartment (458).

VIII. Exemplary User Interface on Holster

In addition to or in lieu of a user interface (700) being provided by avacuum control module (400), a user interface (800) may be provided onbiopsy device (100, 101). For instance, such a user interface (800) maybe provided on a probe (102, 103) and/or on a holster (202, 302). In thepresent example, a merely exemplary user interface (800) is provided onholster (202). Also in the present example, controls provided throughuser interface (700) of vacuum control module (400) relate more tosettings of biopsy system (2), while controls provided through userinterface (800) of holster (202) relate more to actual operation ofbiopsy device (100). It will be appreciated, however, that such rolesmay be reversed or mixed. For instance, user interface (800) may beconfigured to permit a user to adjust at least some settings of biopsysystem (2), and/or user interface (700) may be configured to permit auser operate biopsy device (100).

Referring to FIG. 69, user interface (800) of the present example isprovided as a membrane that is securable to either or both of sidepanels (214, 216). User interface (800) may also be provided, at leastin part, as an in-mold decoration (IMD). Such an IMD configuration mayprovide a seal of holster (202), such that the presence of userinterface (800) does not create undesirable leak points. An IMDconfiguration may nevertheless provide flexible areas for user input,such as buttons (802, 803, 804, 806, 808) described below. In otherembodiments, user interface (800) is provided, at least in part, througha double shot molding process. Other ways in which a user interface(800) may be provided will be apparent to those of ordinary skill in theart in view of the teachings herein.

User interface (800) of the present example comprises five buttons (802,803, 804, 806, 808), each of which will be described in greater detailbelow, though any other suitable number of buttons may be used. In someembodiments, buttons (802, 803, 804, 806, 808) are provided as thin filmswitches as part of the membrane. In other embodiments, buttons (802,803, 804, 806, 808) are formed in the side panel (214, 216) to which themembrane is adhered. In still other embodiments, buttons (802, 803, 804,806, 808) comprise capacitive switches. In the present example, buttons(802, 803, 804, 806, 808) (or at least a perimeter of buttons (802, 803,804, 806, 808)) are lit by LEDs or other sources of light behind amembrane. Other ways in which buttons (802, 803, 804, 806, 808) may beprovided will be apparent to those of ordinary skill in the art in viewof the teachings herein.

Buttons (802, 803) of the present example may be actuated to advance orretract cutter (50), respectively. Such advancement or retraction may beused to selectively reduce the effective aperture (16) size, as notedabove, during a sampling cycle. Alternatively, a user may wish to varyaperture size (16) while aspirating. Other situations in which a usermay wish to advance or retract cutter (50) by activating buttons (802,803) will be apparent to those of ordinary skill in the art in view ofthe teachings herein. As will be described in greater detail below, thecutter (50) position obtained through a user's activation of buttons(802, 803) may be indicated through the discrete lighted sections (812)of a cutter position indicator (810) on user interface (800).

Button (804) of the present example is operable to initiate a samplingcycle. Exemplary sampling cycles are discussed above in detail, and willtherefore not be described in greater detail here. Suitable ways inwhich a button (804) may be made operable to initiate a sampling cyclewill be apparent to those of ordinary skill in the art in view of theteachings herein. Furthermore, in some variations, button (804) alsoperforms the same function of button (802) as described above, such thatbutton (802) may be omitted. Similarly, in other variations, button(802) performs the same function as button (804) as described above,such that button (804) may be omitted.

Button (806) of the present example is operable to initiate a lateralvacuum within probe (102). For instance, actuation of button (806) mayresult in a vacuum being communicated through tube (402), which may inturn be communicated through transverse openings (32). Suitable ways inwhich a button (806) may be made operable to initiate a lateral vacuumwill be apparent to those of ordinary skill in the art in view of theteachings herein.

Button (808) of the present example is operable to initiate a clearprobe cycle. Exemplary clear probe cycles are discussed above in detail,and will therefore not be described in greater detail here. Suitableways in which a button (808) may be made operable to initiate a clearprobe cycle will be apparent to those of ordinary skill in the art inview of the teachings herein.

User interface (800) also includes a cutter position indicator (810),which includes a representation of the distal end of outer cannula (12)and a plurality of discrete lighted sections (812). By way of exampleonly, one or more LEDs or other sources of light may be used toilluminate discrete sections (812). The lighting of discrete sections(812) may serve to indicate the position of cutter (50) relative toaperture (16). For instance, the last lit discrete section (812) mayindicate the distal end of cutter (50). In some embodiments, only thosediscrete sections (812) corresponding to cutter (50) position are lit,while the remaining discrete sections (812) are unlit. In otherembodiments, those discrete sections (812) corresponding to cutter (50)position are lit with one color (e.g., red), while the remainingdiscrete sections (812) are lit with another color (e.g., yellow). Stillother ways in which a cutter position indicator (810) may be used toindicate the position of cutter (50) will be apparent to those ofordinary skill in the art in view of the teachings herein. In addition,there are a variety of ways in which cutter (50) position data may beeffectively communicated to cutter position indicator (810). By way ofexample only, one or more sensors may be communicatively coupled withcutter (50), cutter rotation and translation mechanism (120), and/orcutter drive mechanism (270).

User interface (800) also includes an icon (814) indicating an needlecocking direction for trigger (242), as well as an icon (816) indicatingan unlocking direction for trigger (242). Ways in which trigger (242)may be used to cock and fire (e.g., in conjunction with actuation ofbutton (244)) needle portion (10) are described in greater detail above.Icons (814, 816) may simply provide visual indications of the directionsfor rotating trigger (242) to accomplish such actions.

In addition, user interface (800) includes an error light (820). Errorlight (820) may be selectively lit under a variety of conditions. Forinstance, error light (820) may be lit when a tissue is jammed in cutterlumen (52) or elsewhere within biopsy system (2). Error light (820) mayalso provide “trouble codes” by flashing in a particular sequence orpattern that is associated with a particular condition. For instance,the number of times error light (820) flashes before repeating aflashing sequence may be varied based on error conditions. It will alsobe appreciated that other components of user interface (800) may be usedto communicate one or more error conditions, in lieu of or in additionto error light (820). For instance, discrete sections (812) of cutterposition indicator (810) may flash or be selectively lit in certainpatterns or sequences to indicate certain error conditions. Other waysin which error conditions may be communicated to a user, via lights orotherwise, will be apparent to those of ordinary skill in the art inview of the teachings herein. Similarly, ways in which error conditionsmay be detected will be apparent to those of ordinary skill in the artin view of the teachings herein.

In versions where both sides of a holster (202, 302) have buttons (802,803, 804, 806, 808), biopsy system (2) may be configured to assign thefirst side on which a button (802, 803, 804, 806, 808) is activated asthe “active” side of the holster (202, 302). Similarly, biopsy system(2) may assign the first side on which a trigger (242) or button (244) sactivated as the “active” side of the holster (202, 302). By way ofexample only, in versions providing a “view sample” mode as describedabove, such an assignment of an “active” side may dictate whetherrecently acquired tissue samples (4) are presented at a three o'clockposition or at a nine o'clock position. In other words, if a user firstactivates a button (244, 802, 803, 804, 806, 808) or trigger (242) on aside corresponding to the three o'clock position of tissue sample holder(140, 368), manifold (144, 366) may rotate to present a recentlyacquired tissue sample (4) to the user at a three o'clock position.Alternatively, biopsy system (2) may be configured to vary otherfunctions in response to an assignment of an “active” side, or maysimply not assign an “active” side at all.

It will be appreciated that a variety of components may be used to giveeffect to buttons (802, 803, 804, 806, 808), lighted sections (812), anderror light (820). For instance, one or more printed circuit boards (notshown) may be provided within holster (202). In addition, user interface(800) may be at least partially in communication with vacuum controlmodule (400), such as via cable (484) or otherwise. Other ways in whichuser interface (800) may be incorporated into biopsy system (2), as wellas other variations of user interface (800), will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed an sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. A biopsy device, wherein the biopsy device comprises: (a) a cannulahaving a closed tip, the cannula defining an axis; (b) a cuttertranslatable relative to the cannula, along the axis defined by thecutter; (c) a probe body, wherein the cannula extends distally relativeto the body; and (d) a cutter actuation assembly, wherein the cutteractuation assembly is operable to translate the cutter distally relativeto the cannula along the axis defined by the cutter, wherein the cutteractuation assembly comprises: (i) a sleeve unitarily secured to thecutter, wherein the sleeve comprises: (A) a first portion havingexternal threading, wherein the first portion extends along a firstlongitudinal region of the sleeve, and (B) a second portion havingexternal flats, wherein the second portion extends along a secondlongitudinal region of the sleeve, and (ii) a nut member associated withthe probe body, wherein the nut member has internal threading configuredto engage the external threading of the sleeve, such that the cuttermoves longitudinally upon rotation of the sleeve relative to the nut. 2.The biopsy device of claim 1, wherein the cutter actuation assembly isfurther operable to rotate the cutter about the axis defined by thecannula.
 3. The biopsy device of claim 1, wherein the external threadinghas a fine pitch.
 4. The biopsy device of claim 3, wherein the pitch ofthe external threading is between approximately 40 threads per inch andapproximately 50 threads per inch.
 5. The biopsy device of claim 1,wherein the nut member is stationary relative to the probe body whilethe sleeve rotates.
 6. The biopsy device of claim 5, the cutteractuation assembly further comprising a first gear disposed about thesecond portion of the sleeve and spaced from the first portion of thesleeve, wherein the gear is configured to rotate unitarily with thesleeve.
 7. The biopsy device of claim 6, wherein the second portion ofthe sleeve is configured to translate relative to the first gear.
 8. Thebiopsy device of claim 6, further comprising a holster portion removablyengaged with the probe body.
 9. The biopsy device of claim 8, whereinthe holster portion comprises a second gear configured to mesh with thefirst gear.
 10. The biopsy device of claim 9, wherein the holsterportion further comprises a motor configured to rotate the second gear.11. The biopsy device of claim 1, wherein the cutter actuation assemblycomprises a gear, wherein cutter actuation assembly is configured tosimultaneously rotate and translate the cutter upon rotation of thegear.
 12. The biopsy device of claim 11, wherein the gear is engagedwith the sleeve, wherein the gear is configured to rotate the sleeverelative to the nut.
 13. The biopsy device of claim 12, wherein thesleeve is configured to translate relative to the gear while beingrotated by the gear.
 14. The biopsy device of claim 12, wherein the gearcomprises internal flats complementing the external flats of the sleeve.15. The biopsy device of claim 1, wherein the closed tip of the cannulais configured to pierce tissue.
 16. A biopsy device, wherein the biopsydevice comprises: (a) a cannula having a closed tip, the cannuladefining an axis; (b) a cutter translatable relative to the cannula,along the axis defined by the cutter; (c) a probe body, wherein thecannula extends distally relative to the body; and (d) a cutteractuation assembly, wherein the cutter actuation assembly is operable totranslate the cutter distally relative to the cannula along the axisdefined by the cannula, wherein the cutter actuation assembly comprisestwo complementary threaded members, each threaded member havingthreading, wherein the threading has a fine pitch, and wherein one ofthe two threaded members is configured to remain stationary relative tothe probe body while the other of the two threaded members rotates. 17.The biopsy device of claim 16, wherein the fine pitch is betweenapproximately 40 threads per inch and approximately 50 threads per inch.18. The biopsy device of claim 17, wherein the complementary threadedmembers comprise a sleeve unitarily secured to the cutter and a nutsecured relative to the probe body.
 19. A biopsy device, wherein thebiopsy device comprises: (a) a cannula having a closed tip, the cannuladefining an axis; (b) a cutter translatable relative to the cannula,along the axis defined by the cutter; (c) a probe body, wherein thecannula extends distally relative to the body; and (d) a cutteractuation assembly, wherein the cutter actuation assembly is operable totranslate the cutter distally relative to the cannula along the axisdefined by the cannula and simultaneously rotate the cutter along theaxis defined by the cannula, wherein the cutter actuation assemblycomprises: (i) a sleeve unitarily secured to the cutter, wherein thesleeve includes external threading and external flats, (ii) a nutsecured relative to the housing, wherein the nut includes internalthreading configured to engage the external threading of the sleeve, and(iii) a gear positioned coaxially about the sleeve, wherein the gearincludes internal flats configured to engage with external flats of thesleeve, wherein the sleeve is longitudinally slidable relative to thegear.
 20. The biopsy device of claim 19, wherein the external threadingand the internal threading have a fine pitch.